Beckman Coulter Inc.

FDA recalling firm · 216 enforcement events · 334 product records · 2010–2026 · CA, MN

Beckman Coulter Inc. has 216 FDA enforcement events on this register (334 product records) between 2010 and 2026: 216 device; the busiest year was 2025 with 34.

1% of its events are Class I; the most common class is Class II (207). 79 events are listed as ongoing; the recalling firm's address is in CA and MN.

Recall classification reflects the relative degree of health hazard. Event counts depend on a firm's size and product range; they are not a comparison of one firm with another.

Enforcement events

Initiated	Product (first record)	Type	Class	Records	Status
15 Jul 2026	Beckman Coulter DxC 500i Clinical Analyzer Modules using software version 1.5 or lower: 1) DxC 500 AU Module w/ISE, DxC 500i, Part Number C63522; 2) DxC 500 AU Module, DxC 500i, Part Number C63521; 3) Access 2 Module, DxC 500i, Part Number C13252; DxC 500 AU Clinical Chemistry Analyzers	Device	Class II	2	Ongoing
26 Jun 2026	REF # D23352, MicroScan LabPro V5.03 Panel Update 11 (US), Electronic installed on the following instruments: - B1018-280 MicroScan autoSCAN-4 Instrument - B1018-283 MicroScan WalkAway-40 plus Instrument - B1018-284 MicroScan WalkAway-96 plus Instrument - B1018-440 DxM-1040 MicroScan WalkAway Instrument - B1018-496…	Device	Class II	2	Ongoing
16 Mar 2026	Access Total T4 Calibrator, Catalog No. 33805	Device	Class II	1	Ongoing
23 Dec 2025	CellMek SPS Sample Preparation System, REF: C44603, with software	Device	Class II	1	Ongoing
26 Nov 2025	Beckman Coulter UniCel Dxl 600, Part numbers: A71460, A71461, A30260; Immunoassay Method, Troponin Subunit	Device	Class II	2	Ongoing
10 Nov 2025	COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For use as an isotonic buffered diluent in conjunction with a cyanide-free lytic agent for counting and sizing blood cells on all UniCel DxH Coulter Cellular Analysis Systems. For use as a rinsing agent on the UniCel DxH Slidemaker Stainers. For use…	Device	Class II	1	Ongoing
7 Nov 2025	Access 2 Reaction Vessels, individual, disposable, plastic tubes used to process patient, quality control and calibration samples on the Access 2 Immunoassay system, Catalog Number 81901	Device	Class II	1	Ongoing
1 Oct 2025	Beckman Coulter UniCel DxI 600, Part Numbers: A71460, A30260; Photometric Chemistry Analyzer	Device	Class II	2	Ongoing
22 Sep 2025	DxFLEX Flow Cytometer Catalog Number C78500 UDI-DI code: 15099590754013 The DxFLEX Flow Cytometer is intended for use as an in vitro diagnostic device for immunophenotyping up to ten fluorescent detection channels using three lasers (488 nm, 638 nm and 405 nm) and two light scatter detection channels. It is intended…	Device	Class II	1	Ongoing
19 Sep 2025	DxC 500i Clinical Analyzer Modules, DxC 500 AU Module w/ISE, DxC 500i (Part Number C63522), DxC 500 AU Module, DxC 500i (Part Number C63521), and Access 2 Module, DxC 500i (Part Number C13252)	Device	Class II	2	Ongoing
17 Sep 2025	SYNCHRON Systems Direct LDL Cholesterol (LDLD) Reagent, REF: 969706	Device	Class II	1	Ongoing
8 Sep 2025	CellMek SPS Sample Preparation System, REF: C44603. Software versions 2.2.122.0 and prior, and Instructions for Use (IFU) revisions AD and prior. These CellMek devices include Cassette E.	Device	Class II	1	Ongoing
8 Sep 2025	MicroScan Neg Multidrug Resistant MIC 1 REF C32368 UDI-DI code: 15099590720568 Intended Use- For use with MicroScan Dried Gram Negative MIC/Combo Panels and Dried Gram Negative Breakpoint Combo Panels. MicroScan panels are designed for use in determining antimicrobial agent susceptibility and/or identification to the…	Device	Class II	1	Ongoing
3 Sep 2025	SYNCHRON Systems Phosphorus (PHOSm) Reagent REF: 467868 For In Vitro Diagnostic Use, Rx Only.	Device	Class II	1	Ongoing
13 Aug 2025	UniCel DxH 900 COULTER Cellular Analysis System, configured with the Led HGB Photometer REF: C11478	Device	Class II	4	Ongoing
4 Aug 2025	DxC 500 AU Module w/ISE, DxC 500i, With ISE, REF: C63522 and DxC 500 AU Module, DxC 500i, Without ISE, REF: C6352; part of the DxC 500i Clinical Analyzer	Device	Class II	1	Ongoing
24 Jul 2025	MicroScan Neg MIC 56 REF C42464 UDI-DI code: 15099590731212 MicroScan panels are designed for use in determining antimicrobial agent susceptibility and/or identification to the species level of aerobic and facultatively anaerobic gram-negative bacilli.	Device	Class II	1	Ongoing
10 Jul 2025	Access Thyroglobulin assay, a simultaneous one-step immunoenzymatic assay, Catalog Number 33860	Device	Class II	1	Ongoing
26 Jun 2025	UIBC (Unsaturated Iron Binding Capacity), REF: OSR61205,	Device	Class II	1	Ongoing
25 Jun 2025	UniCel DxI 800 Access Immunoassay Analyzer, Part Number 973100	Device	Class II	6	Ongoing
25 Jun 2025	MicroScan Neg MIC 3J REF C54814	Device	Class II	1	Ongoing
12 Jun 2025	Estrone RIA, REF: DSL8700. Estrone RIA is an IVD used for the quantitative measurement of estrone in human serum and plasma.	Device	Class II	1	Ongoing
7 May 2025	DxI 9000 Access Immunoassay Analyzer C11137	Device	Class II	1	Ongoing
5 May 2025	Access Testosterone assay, Catalog Number 33560	Device	Class II	1	Ongoing
23 Apr 2025	DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, running software version 1.20	Device	Class II	1	Ongoing
23 Apr 2025	DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, running software versions 1.20	Device	Class II	1	Ongoing
8 Apr 2025	REMISOL Advance UDI-DI code: 13700962601874 All Software Versions: B92487; B92488; C24317; C28652; C37500; D04164; C44703; C57017; C69412; C69413; C73942; C73941; C88470; C88471 The Normand Info REMISOL Advance Data Manager collects and manages data and workflow for 128 connections (Beckman Coulter Instruments,…	Device	Class II	1	Ongoing
27 Mar 2025	Beckman Coulter DxI 9000 Access Immunoassay Analyzer	Device	Class II	1	Ongoing
20 Mar 2025	DxC 500 AU Clinical Chemistry Analyzer, Catalog Numbers/UDI codes: C63519 / 14987666545058 C63520 / 14987666545065. The Beckman Coulter DxC 500 AU Clinical Chemistry Analyzer is an automated chemistry analyzer that measures analytes in samples, in combination with appropriate reagents, calibrators, quality control…	Device	Class II	1	Ongoing
17 Mar 2025	DxC 500 AU Clinical Chemistry Analyzer, Catalog Numbers/UDI codes: C63519 / 14987666545058 C63520 / 14987666545065 Software versions: V1.3, V1.4, V1.4.1, V1.4.2, V1.4.3 The Beckman Coulter DxC 500 AU Clinical Chemistry Analyzer is an automated chemistry analyzer that measures analytes in samples, in combination with…	Device	Class II	1	Ongoing
27 Feb 2025	Access Vitamin B12 Reagent, Catalog Number 33000, Lot Number 439850	Device	Class II	1	Completed
26 Feb 2025	DxC 500 AU Clinical Chemistry Analyzer, Catalog Numbers/UDI codes: C63519 / 14987666545058 C63520 / 14987666545065 The Beckman Coulter DxC 500 AU Clinical Chemistry Analyzer is an automated chemistry analyzer that measures analytes in samples, in combination with appropriate reagents, calibrators, quality control…	Device	Class II	1	Ongoing
6 Feb 2025	DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, with Component PCB, TSI/RSI firmware C29278	Device	Class II	1	Ongoing
5 Feb 2025	Access 2 Immunoassay Analyzer, Catalog Number 81600N	Device	Class II	1	Ongoing
5 Feb 2025	DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137.	Device	Class II	1	Ongoing
3 Feb 2025	Access Erythropoietin (EPO), Catalog Number - A16364 a glycoprotein (~30,400 Daltons) produced primarily by the kidney, is the principal factor regulating red blood cell production (erythropoiesis) in mammals. Renal production of EPO is regulated by changes in oxygen availability. Under conditions of hypoxia, the…	Device	Class II	1	Ongoing
2 Jan 2025	Access PCT Reagent Pack, Catalog Number C53987, when used on Access 2 and UniCel Dxl Immunoassay Systems	Device	Class II	1	Ongoing
26 Nov 2024	Access Intact PTH assay, a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of intact parathyroid hormone (parathyrin, PTH) levels in human serum and plasma using the Access Immunoassay Systems, Catalog Number A16972	Device	Class II	1	Ongoing
18 Nov 2024	Access hsTnI Reagent, REF B52699, Immunoassay Method, Troponin Subunit. For the quantitative determination of cardiac troponin I (cTnI) levels in human serum and plasma.	Device	Class II	1	Ongoing
13 Nov 2024	DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137	Device	Class II	1	Ongoing
8 Nov 2024	Access Intact PTH assay on the DxI 9000 Access Immunoassay Analyzer, Catalog number A16972, for the quantitative determination of intact parathyroid hormone (parathyrin, PTH) levels in human serum and plasma.	Device	Class II	1	Ongoing
30 Sep 2024	The Access Cortisol assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of cortisol levels in human serum, plasma (heparin, EDTA) and urine using the Access Immunoassay Systems.	Device	Class II	1	Ongoing
5 Sep 2024	Access Thyroglobulin Antibody II, REF A32898, containing Instructions for Use, IFU REF B14994, B63978, and A38168. The Access Thyroglobulin Antibody II (TgAb) assay is used for the quantitative determination of thyroglobulin antibody levels in human serum and plasma using the Access Immunoassay Systems.	Device	Class II	1	Ongoing
28 Aug 2024	The Access TSH (3rd IS) assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative etermdination of human thyroid-stimulating hormone (thyrotropin, TSH, hTSH) levels in human serum and plasma using the Access Immunoassay Systems. Measurements of thyroid stimulating hormone produced by the…	Device	Class II	1	Ongoing
31 Jul 2024	IMMAGE Immunochemistry Systems IGM Immunoglobulin M Reagent REF 447610 IGM reagent, when used in conjunction with IMMAGE Immunochemistry Systems and Calibrator 1, is intended for the quantitative determination of immunoglobulin M (IGM) in human serum by rate nephelometry.	Device	Class II	1	Ongoing
16 Jul 2024	Beckman Coulter IRISPEC CA/CB/CC Urine Chemistry Controls, Catalog Number REF 800-7211 and 800-7702, in vitro diagnostic device.	Device	Class III	1	Ongoing
12 Jul 2024	DxI 9000 Access Immunoassay Analyzer, catalog number C11137 in vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body fluids	Device	Class II	1	Ongoing
10 Jul 2024	Beckman Coulter DxI 9000 Access Immunoassay Analyzer, Model Number C21510, RSM Pneumatic Tubing Kit item #2, REF C11137; in vitro diagnostic instrument	Device	Class II	1	Ongoing
14 Jun 2024	Discrete photometric chemistry analyzer for clinical use.	Device	Class II	1	Ongoing
4 Jun 2024	Dxl 9000 Access Immunoassay Analyzer, Catalog #C11137.	Device	Class II	1	Ongoing
27 May 2024	Beckman Coulter, REF: OSR61173, IGM 4x14 mL R1, 4x11 mL R2	Device	Class II	1	Ongoing
22 May 2024	Beckman Coulter DxI 9000 Access Immunoassay Analyzer, Catalog #C11137.	Device	Class II	1	Ongoing
22 May 2024	DxI 9000 Access Immunoassay Analyzer, Catalog #C11137.	Device	Class II	1	Ongoing
18 Apr 2024	DxI 9000 Access Immunoassay Analyzer, C11137; in-vitro diagnostic	Device	Class II	1	Ongoing
18 Apr 2024	Beckman Coulter Dxl 9000 Access Immunoassay Analyzer, REF #C11137. An in vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body fluids.	Device	Class II	1	Ongoing
5 Mar 2024	DxI 9000 Access Immunoassay Analyzer, REF C11137, vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body fluids.	Device	Class II	1	Ongoing
29 Feb 2024	Beckman Coulter DxI 9000 Access Immunoassay Analyzer is a discrete photometric chemistry analyzer for clinical use. It is an in-vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body fluids with Catalog Number C11137.	Device	Class II	1	Ongoing
8 Feb 2024	Access Total T4, REF 33800, IVD, thyroxine reagent assay.	Device	Class II	1	Ongoing
7 Feb 2024	Access Substrate, REF 81906, For use with the Access Immunoassay Systems	Device	Class II	1	Ongoing
3 Jan 2024	Beckman Coulter DxI 9000 Access Immunoassay Analyzer, catalog number C11137; in-vitro diagnostic instrument	Device	Class II	1	Completed
19 Dec 2023	Beckman Coulter DxU 850m/840m Microscopy Analyzers, Part Numbers: C49513, C76947	Device	Class II	4	Ongoing
21 Nov 2023	Access Ultrasensitive Insulin only used on the DxI 9000 Access Immunoassay Analyzer, Catalog Number 33410	Device	Class II	2	Ongoing
12 Sep 2023	DxI 9000 Access Immunoassay Analyzer, REF C11137, Sofware Versions 1.15 and below; invitro diagnostic	Device	Class II	1	Ongoing
12 Jul 2023	Beckman Coulter, IVD, REF: OSR61171, IgA, 4 x 14 mL R1, 4 x 11 mL R2	Device	Class II	1	Ongoing
6 Jul 2023	Access Thyroglobulin Calibrators	Device	Class II	1	Ongoing
20 Jun 2023	Ringed DxI Reaction Vessels (RVs)	Device	Class II	1	Ongoing
31 May 2023	COULTER DxH Diluent, REF 628017; diluent used for counting and sizing blood cells	Device	Class II	1	Ongoing
17 May 2023	Access Hybritech p2PSA reagent, REF B03704 and REF A49752.	Device	Class II	1	Ongoing
5 Apr 2023	iQ200 Series Urine Microscopy Analyzer: a) iQ 200 Select, Part Numbers C10684 and 700-3345; b) iQ 200 Elite, Part Numbers C10683 and 700-3375; in-vitro diagnostic device, urine analysis, c) iQ200 Select 1500, Part Number 700-3347, d) iQ200 Sprint, Part Number 700-3325	Device	Class II	4	Ongoing
5 Apr 2023	Beckman Coulter Bicarbonate, REF: OSR6137, 4x25 mL	Device	Class II	3	Ongoing
15 Mar 2023	Beckman Coulter Access Free T3, Triiodothyronine, Free, Catalog #A13422, each box contains 2 reagent packs.	Device	Class II	1	Ongoing
26 Jan 2023	Access Immunoassay Systems (1) Access 2 Immunoassay Analyzer (81600N); (2) Access 2 Immunoassay Analyzer, Refurbished (386220); (3) Access 2 Immunoassay Analyzer, Refurbished (A65531) ; and (4) Access 2 Section, DxC 600i Packaged(A25640).	Device	Class II	1	Ongoing
18 Nov 2022	BECKMAN COULTER IRISpec CA/CB/CC control, REF 900-7211, For in vitro diagnostic use only.	Device	Class II	1	Ongoing
3 Oct 2022	MicroScan autoSCAN-4 Instrument, Catalog Number B1018-280	Device	Class II	1	Ongoing
16 Feb 2022	Beckman Coulter IRISpec CA/CB/CC control, Catalog #800-7211, containing 3 x 100 mL bottles each of CA Control, CB Control, and CC Control.	Device	Class III	1	Ongoing
8 Dec 2021	AU/DxC AU Magnesium, Catalog/REF Number OSR6189, UDI 15099590010850	Device	Class II	1	Terminated
10 Nov 2021	SYNCHRON Systems Cholesterol (CHOL) Reagent, REF: 467825	Device	Class II	1	Ongoing
9 Aug 2021	Access hsTnI High Sensitivity Troponin I, REF B52699 Access Immunoassay System REAGENT PACK	Device	Class II	1	Ongoing
5 Aug 2021	Access SARS CoV-2 IgG (1st IS) Assay: Access Immunoassay Systems REAGENT PACK, REF C74339 Access SARS-CoV-2 IgG (1st IS) Calibrators, REF C74340 Access SARS-CoV-2 (1st IS) Quality Control (QC), REF C74341	Device	Class II	1	Terminated
28 Jul 2021	Power Processor 3K, 3K High Speed Stockyards Module Nameplate: PP 3K Stockyard (Refrig) 9707 REF A88116	Device	Class II	1	Ongoing
21 Jul 2021	DxA 5000 (DxA Automation System, DxA 5000 fit), "For in Vitro Diagnostic Use", Reference Numbers: B87352 with B57634, UDI: 15099590707118	Device	Class II	1	Terminated
15 Jul 2021	Normand Remisol Advance Data Manager, REF: C69412, C69413, C44703, and C57017 is a software device that interfaces between laboratory information systems (LIS) and laboratory instruments.	Device	Class II	1	Terminated
1 Jul 2021	ACCESS SARS-CoV-2 Antigen , REF: C68668, IVD, Rx only, UDI: (01) 15099590742713;	Device	Class II	4	Terminated
23 Jun 2021	Kaluza C Flow Cytometry Software Versions: 1.0*, 1.1.1 and 1.1.2 Kits: C10574 - Kaluza C Single Perpetual License C10575 - Kaluza C Single User 1-year License C10576 - Kaluza C 10 User Network License C10577 - Kaluza C 5 User Network License C10578 - Kaluza C Single Perpetual Educational License C10579 - Kaluza C…	Device	Class II	1	Terminated
7 May 2021	Access SARS CoV-2 lgG II Reagent, REF: C69057, IVD CE UDI: (01)15099590742744	Device	Class II	2	Terminated
14 Apr 2021	Access SARS-CoV-2 Antigen, REF C68668, UDI: (01)15099590742713, 3.30 mL/R1a, 4.70 mL/R1b, 4.20 mL/R1c, 3.10 mL, R1d, 3.10 mL, R1e	Device	Class II	1	Terminated
30 Dec 2020	ACCESS SARS-CoV-2 IgG QC SARS-CoV-2 IgG REF C58964 - Product Usage: use on the Access Family of Immunoassay Systems only.	Device	Class II	1	Terminated
2 Dec 2020	MicroScan Pos MIC Panel Type 34 - Product Usage: For the determination of antimicrobial agent susceptibility and/or identification to the species level of rapidly growing aerobic and facultative gram-positive cocci, some fastidious aerobic cocci and listeria monocytogenes.	Device	Class II	1	Terminated
26 Aug 2020	BECKMAN COULTER ACCESS Immunoassay Systems - Access Unconjugated Estriol, REF 33570.	Device	Class II	1	Terminated
18 Aug 2020	UIBC; Catalog Number: OSR61205; UDI (01) 15099590011925; IVD; Rx Only; WARNING H316 H317 H351 H373 H411 - Product Usage: System reagent for the quantitative determination of Unsaturated Iron Binding Capacity (UIBC) in human serum and plasma on Beckman Coulter AU analyzers.	Device	Class II	1	Terminated
30 Mar 2020	iChem¿VELOCITY Urine Chemistry System-	Device	Class II	2	Terminated
17 Feb 2020	iChemVELOCITY Strips, Catalog 800-7212	Device	Class II	1	Terminated
29 Jan 2020	ISE Electrolyte Reference (2 X 2L) Reagent, REF A28937, UDI: 15099590202491 - Product Usage: are intended for the quantitative determination of carbon dioxide in human serum or plasma.	Device	Class II	1	Terminated
17 Jan 2020	LabPro Data Management System, UDI: 15099590676872 - Product Usage: The LabPro Data Management System is a Microsoft Windows based software program and is intended to manage both microbial identification (ID) and antimicrobial agent susceptibility testing (AST) data generated from MicroScan instruments or manually…	Device	Class II	1	Terminated
13 Dec 2019	Beckman Coulter MicroScan PROMPT Inoculation System-D, Catalog Number B1026-10D, UDI: 15099590659561 - Product Usage: The Prompt Inoculation System-D is used to standardize inocula for microdilution antimicrobial susceptibility test.	Device	Class II	1	Terminated
7 Nov 2019	iChem VELOCITY Urine Chemistry Analyzer	Device	Class II	1	Terminated
28 Oct 2019	iChemVELOCITY, Urine Chemistry System, Catalog numbers: 700-7176-001, 700-7177-001, B75502 - Product Usage: used to automate the urine chemistry analysis profile using iChem¿ VELOCITY Urine Chemistry Strips.	Device	Class II	2	Terminated
21 Oct 2019	MicroScan WalkAway-40 plus Instrument REF B1018-283	Device	Class II	6	Ongoing
7 Oct 2019	UniCel DxH Slidemaker Stainer (DxH SMS) and UniCel DxH Slidemaker Stainer II (DxH SMS II) - Product Usage: The intended use is as follows: The DxH Slidemaker Stainer is a fully automated slide preparation and staining device that aspirates a whole-blood sample, smears a blood film on a clean microscope slide, and…	Device	Class II	1	Terminated
4 Sep 2019	MicroScan WalkAway-40 plus Instrument	Device	Class II	4	Terminated
4 Sep 2019	Synchron Systems Opiate 2000 ng Reagent (OP2 1 x 250); catalogue no. 475006 for use in conjunction with UniCel DxC 600/800 System(s) and SYNCHRON Systems Drugs of Abuse Testing (DAT) Urine Calibrators. The assay provides a rapid screening procedure for presence of the analyte in urine.	Device	Class II	2	Terminated
15 Aug 2019	Enzymatic Creatinine Reagent (CR-E 2 X 200), REF A60298, For in Vitro Diagnostic Use, Rx Only, UDI: 15099590625733	Device	Class II	5	Terminated
12 Jun 2019	SYNCHRON Systems Barbiturates Reagent (BARB 1 X 250); Catalog No. 475012 - Product Usage: BARB reagent, in conjunction with UniCel DxC 600/800 System(s) and SYNCHRON Systems Drugs of Abuse Testing (DAT) Urine Calibrators, is intended for the qualitative determination of barbiturates in human urine at a cutoff value…	Device	Class II	1	Terminated
17 May 2019	Beckman Coulter Power Express Sample Processing System AU5800XL connection unit, catalog #B36351; and Power Express Dynamic Inlet, catalog B36352.	Device	Class II	1	Terminated
30 Apr 2019	Beckman Coulter Access Immunoassay Systems, Access Free T4 Thyroxine, REF 33880 (UDI:15099590225834) for use with Access Family of Immunoassay Systems including: Access 2, UniCel DxI 600, UniCel DxI 800, UniCel DxC 600i, UniCel DxC 660i, UniCel DxC 680i, UniCel DxC 860i, and UniCel DxC 880i systems.	Device	Class II	6	Terminated
5 Dec 2018	The UniCel DxI 600 and 800 Access Immunoassay Systems, that are connected to an automation line. UniCel DxI 600 Catalog Numbers: A30260, A71460, A71461, A92060. Unicel DxI 800 Catalog Numbers: 973100, A71456, A71457, A84545, A25288, A25285.	Device	Class II	2	Ongoing
9 Nov 2018	AutoMate 1250, Sorter with Aliquot Module - UDI: 15099590364106; Model #ODL25125 Automate 2550, High Speed Sorter with Aliquot Module - UDI: 15099590364083 , Model #ODL25255	Device	Class II	1	Ongoing
18 Oct 2018	iChem VELOCITY Urine Chemistry Strips, REF 800-7212, 100 test strips/vial. The firm name on the label is Beckman Coulter Ireland, Inc., Co. Clare, Ireland, Made in Germany.	Device	Class II	1	Terminated
18 Sep 2018	The Access Cortisol Reagent. REF (Catalog Number) 33600, Lot 831755. A paramagnetic particle, chemiluminscent immunoassay. Product Usage: The assay is a paramagnetic particle, chemiluminescent immunoassay for the quanitative determination of cortisol levels in human serum, plasma (heparin, EDTA) and urine using the…	Device	Class II	1	Terminated
17 Sep 2018	Kaluza C Flow Cytometry Software, RX Only in the U.S.A., Beckman Coulter, Inc. for the following software devices: (A) Kaluza C Perpetual License (B) Kaluza C Single Use 1 Year License (C) Kaluza C 5 User Network (D) Kaluza C 10 User Network (E) Kaluza C Perpetual Educational License (F) Kaluza C Single User 1 Year…	Device	Class II	1	Terminated
24 Aug 2018	Beckman Coulter Lipase, REF OSR6130 and OSR6230.	Device	Class II	2	Terminated
30 Jul 2018	UniCel DxH 800 Coulter Cellular Analysis System, REF numbers 629029, B24465, B24802, B68304, B66445, and B63322. Product Usage: The UniCel DxH 800 Analyzer is a quantitative multi-parameter, automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories. The…	Device	Class I	3	Terminated
24 May 2018	Intelligent Peri-Analytical Workstation (HW+SW), Catalog #: A89492 (iPAW Software v4.2.1), Beckman Coulter, Inc. The iPAW ((intelligent Peri-Analytical Workstation) can act as: a software client for specimen tracking and workload statistics or a physical workstation for manual sorting and label printing.	Device	Class III	7	Terminated
4 May 2018	MicroScan Pos Combo Panel Type 43, Catalog number B1017-217for use in determining antimicrobial agent susceptibility and/or identification to the species level of rapidly growing aerobic and facultative gram-positive cocci, some fastidious aerobic gram-positive cocci and Listeria monocytogenes.	Device	Class II	1	Terminated
29 Mar 2018	iChem VELOCITY Automated Urine Chemistry System, Catalog #700-7176-001 and iChem VELOCITY Automated Urine Chemistry System Computerless, Catalog #700-7177-001. The iChemVELOCITY automated urine chemistry system is an in-vitro diagnostic device used to automate the urine chemistry analysis profile using iChemVELOCITY…	Device	Class II	1	Terminated
26 Mar 2018	BECKMAN COULTER MicroScan MICroSTREP Plus Panel, MicroScan Mueller-Hinton Broth with 3% lysed horse blood, Catalog Number 81015 MicroScan Mueller Hinton Broth with 3% Lysed Horse Blood is used for inoculation of MicroScan MICroSTREP plus and MicroFAST panels. MICroSTREP plus panels are designed for use in determining…	Device	Class II	1	Terminated
2 Mar 2018	BECKMAN COULTER iChemVELOCITY, Urine Chemistry System, Catalog Numbers: 800-3530, 800-7167, 800-7719, 800-7720, 800- 7106, 800-3049, 800-3050, 800-3079, 800-3080, 800-7190, 800-7713, 800-7714, 800-7715, 700- 7176-001, 700-7177-001 Product Usage: The iChemVELOCITY automated urine chemistry system is an in vitro…	Device	Class II	1	Terminated
2 Mar 2018	BECKMAN COULTER iQ200 Series Urine Microscopy Analyzer, Catalog Numbers: 700-3345, C10684, 700-3375, C10683, 700-3325, 700-3347, 700-3320, 700-3322, 700-3370	Device	Class II	1	Terminated
29 Jan 2018	AQUIOS CL Flow Cytometer System, Catalog #B30166. The AQUIOS CL Flow Cytometer system is an automated analyzer that use a no-wash sample preparation process.The firm name on the label is Beckman Coulter Ireland, Inc., Co. Clare, Ireland.	Device	Class II	1	Terminated
19 Jan 2018	AutoMate 1200 Catalog Number ODL25120; AutoMate 1250 Catalog Number ODL25125; AutoMate 2500 Catalog Number ODL25250; AutoMate 2550 Catalog Number ODL25255	Device	Class II	1	Completed
18 Jan 2018	AutoMate 2550 "High Speed" Catalog Number ODL25255; AutoMate 1250 "Standard" Catalog Number ODL25125. Chemistry analyzer sample processing and sorting system.	Device	Class II	1	Terminated
12 Jan 2018	1) Cytomics FC 500 With CXP Software BECKMAN COULTER 2) Cytomics FC 500 MPL With MXP Software BECKMAN COULTER flow cytometer for in vitro diagnostics	Device	Class I	2	Terminated
4 Dec 2017	iChem VELOCITY Urine Chemistry Strips, REF 800-7212 Product Usage: The iChem VELOCITY automated urine chemistry system is an in vitro diagnostic deice used to automate the urine chemistry analysis profile using iChem VELOCITY Urine Chemistry Strips. The iChem VELOCITY can be used as a stand alone-system, as well as…	Device	Class II	1	Terminated
10 Nov 2017	iQ200 Series Urine Microscopy Analyzer with Barcode Reader Model NFT-2100, Catalog #s: 800-3046, 800-3047, 800-3052, 800-3053, 800-3802, 800-3803, 800-3900, 800-3920, 800-3925, 800-3931, 800-3933, 800-3934, 800-3935, 800-3937, 800-3950, 800-3951, 800-3042, 800-3043, 800-3044, 800-3049, 800-3050, 800-7190, 800-7713,…	Device	Class II	1	Terminated
6 Nov 2017	Access 2 Immunoassay System, Catalog Number 81600N. In vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body fluids.	Device	Class III	3	Terminated
3 Nov 2017	UniCel DxH800, Part Numbers: 629029 and B24802, automated hematology analyzer	Device	Class II	3	Terminated
2 Oct 2017	AQUIOS CL Flow Cytometer, Catalog No. B30166, Rx. The firm name on the label is Beckman Coulter Ireland Inc., Ireland. The AQUIOS CL Flow Cytometer is intended for use as an in vitro diagnostic device for immunophenotyping. It is used in conjunction with the following reagents and software package: AQUIOS Tetra-1…	Device	Class II	1	Terminated
24 Aug 2017	Lyophilized Chemistry Calibrator Level 1 Product Usage: Beckman Coulter Chemistry Calibrators are intended for use when calibrating methods run on the Beckman Coulter AU series of chemistry analyzers. Beckman Coulter Chemistry Calibrators are lyophilized, human serum based products formulated for use as a reference…	Device	Class II	1	Terminated
21 Aug 2017	AQUIOS CL Flow Cytometer System The AQUIOS CL Flow Cytometer is intended for use as an in vitro diagnostic device for immunophenotyping.	Device	Class II	1	Terminated
3 Aug 2017	Power Processor 1K Stockyard. The Power Processor performs all pre-analytical sample tube preparation.	Device	Class II	1	Terminated
20 Jul 2017	Sekisui Diagnostics Sekure Chemistry Acetaminophen L3K , Ref. 506-30. The firm names on the label are Sekisui Diagnostics (UK) Limited, United Kingdom, and Sekisui Diagnostics P.E.I. Inc., Canada. Used in laboratory testing.	Device	Class II	1	Terminated
26 Jun 2017	Coulter LH 750, Coulter LH 780, and Coulter LH 500 Analyzers Hematology Analyzers are quantitative, automated hematology analyzers and leukocyte differential counters For In Vitro Diagnostic used in clinical laboratories. They also provide automated Reticulocyte analysis and enumeration of nucleated red blood cells…	Device	Class II	2	Terminated
20 Jun 2017	UniCel DxH Slidemaker Stainer Coulter Cellular Analysis System, Software Version 3.2. The DxH Slidemaker Stainer allows for adaptation of the smear appearance and stain methodology according to user preferences. Blood smears produced by the Slidemaker portion of the DxH Slidemaker Stainer are moved to baskets for…	Device	Class II	1	Terminated
22 May 2017	Coulter PrepPlus, Part Number 286600, Product Usage: The COULTER PrepPlus is a microprocessor-controlled pipetting and diluting system designed for automating sample preparation or assay methods. It is capable of aspirating and dispensing liquid samples.	Device	Class II	2	Terminated
15 May 2017	Beckman Coulter Synchron AQUA CAL Level 1, Part No. 471288 Product Usage: Used for the system calibration of Na, K, Cl, Urea N, Urea, Glucose Creatine, Ca, CO2, and P in UniCel DxC Systems.	Device	Class II	1	Terminated
9 May 2017	Access Total T3, A34435H, Catalog No. 33830	Device	Class II	4	Terminated
24 Apr 2017	UniCel DxH 800 Coulter Cellular Analysis System, Catalog No. 629029, B24465, B24802, B66445, B68304, B63322.	Device	Class II	2	Terminated
24 Apr 2017	Microalbumin Reagent, Catalog No. 475100, Product Labeling A18520AL MA reagent, when used in conjunction with UniCel DxC 600/800 System(s) and SYNCHRON¿ Systems MA Calibrator, is intended for quantitative determination of Albumin concentration in human urine	Device	Class II	1	Terminated
13 Apr 2017	Access BR Monitor, Part No. 387620	Device	Class II	1	Terminated
3 Apr 2017	AQUIOS CL Flow Cytometer, Ref no. B30166, Software Versions 2.0 and 2.0.1 Product Usage: The AQUIOS CL Flow Cytometer is intended for use with in vitro diagnostic flow cytometric applications using up to four fluorescent detection channels using a blue (488 nm) laser, two light scatter detection channels and…	Device	Class II	1	Terminated
3 Apr 2017	Lactate Reagent (LACT 2 x 50), Catalog No. A95550 Intended for the quantitative determination of Lactate concentration in human plasma and cerebrospinal fluid (CSF).	Device	Class II	7	Terminated
10 Mar 2017	Access Ferritin Calibrators, Part No. 33025, Ref No. B50136C	Device	Class II	1	Terminated
7 Mar 2017	Access 2 Immunoassay Systems, Part No. 81600N Product Usage: The Access 2 and UniCel DxI Access Immunoassay Systems are in vitro diagnostic devices used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids.	Device	Class II	3	Terminated
13 Feb 2017	Beckman Coulter Chemistry Analyzer AU680/AU5800, Catalog No. MU907400 (Rack ID Labels) The Beckman Coulter AU680 and the AU5800 Clinical Chemistry Analyzers are an automated chemistry analyzer that measures analytes in samples, in combination with appropriate reagents, calibrators, quality control (QC) material and…	Device	Class II	1	Terminated
30 Jan 2017	iChemVELOCITY Urine Chemistry System, Catalog No. 800-3530, 800-7167, 800-7719, 800-7720, 800-3564, 800-7100, 800-7103, 800-7106, 800-7162, 800-7163, 800-7166, 800-3061. The iChem Velocity automated urine chemistry system is used to test for the following analytes in urine: ketones, blood, protein, glucose,…	Device	Class II	1	Terminated
21 Dec 2016	AutoMate 2500 Family Catalog No. ODL25120 AutoMate 1200, ODL25125, AutoMate 1250, ODL25250 AutoMate 2500, ODL25255 Automate 2550. AutoMate 1200/1250/2500/2550 System Series is a semi-open, pre- and post-analytical sample processing and sorting system. The base system automates the sample sorting, decapping, and…	Device	Class III	1	Terminated
19 Dec 2016	UniCel DxH 800 Coulter Cellular Analysis System, Catalog No. 629029, B24465, B24802, B68304	Device	Class II	2	Terminated
25 Oct 2016	MicroScan LabPro Data Management System. Intended to manage both microbial identification (ID) and antimicrobial agent susceptibility testing (AST) data generated from MicroScan instruments or manually entered microbiology test results, for use by trained laboratory personnel.	Device	Class II	1	Terminated
24 Oct 2016	Access Ostase Calibrators, Catalog No. 37305, B83876 Product Usage: The Access Ostase Calibrators are intended to calibrate the Access Ostase assay for the quantitative determination of bone alkaline phosphatase (BAP) levels in human serum and plasma using the Access Immunoassay Systems.	Device	Class II	2	Terminated
19 Oct 2016	AQUIOS Lyse Reagent Kit, Catalog No. B23538 Product Usage: AQUIOS Lysing Reagent Kit is used as part of the AQUIOS flow cytometer system. The kit consists of two reagents used by AQUIOS flow cytometers to prepare whole blood samples for analysis of white blood cells.	Device	Class II	1	Terminated
6 Sep 2016	AQUIOS CL Flow Cytometer, Catalog No. B30166; Intended for use with in vitro diagnostic flow cytometry applications using up to four florescent detection channels.	Device	Class II	1	Terminated
8 Aug 2016	UniCel DxH 800 and DxH 600 Coulter Cellular Analysis System. Catalog No. 629029, B24465, B24802, B68304 (Unicel DxH 800 Coulter Cellular Analysis System). Catalog No. B23858 (Unicel DxH600 Coulter Cellular Analysis System).	Device	Class II	1	Terminated
4 Aug 2016	UniCel DxH Slidemaker Stainer Coulter Cellular Analysis System, Catalog No. 775222 UniCel DxH Slidemaker Stainer (DxH SMS) Instructions for Use (IFU) Part Number B26647AC The DxH Slidemaker Stainer is a fully automated slide preparation and staining device that aspirates a whole-blood sample, smears a blood film on a…	Device	Class II	1	Terminated
27 Jun 2016	The Synchron Systems No Foam DxC (Reference No. B64130) affects the UniCel DxC System (chemistry analyzer). All lots of No Foam DxC reagent are affected by this recall.	Device	Class II	1	Terminated
8 Jun 2016	Access Free T3 Assay, Ref No. A13422 The Access Free T3 assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of free triiodothyronine levels in human serum and plasma using the Access Immunoassay Systems.	Device	Class II	1	Terminated
17 May 2016	Access 2 Immunoassay System, Remanufactured, Catalog No. 386220 is an invitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analytes concentrations found in human body fluids.	Device	Class II	1	Terminated
13 Apr 2016	Lipase, Catalog No. OSR6x30 Product Usage: Lipase OSR6x30 is intended as a System reagent for the quantitative determination of Lipase activity in human serum on Beckman Coulter AU analyzers.	Device	Class II	5	Terminated
11 Feb 2016	MicroScan LabPro Information Manager System, Software Versions 1.0 to 4.41 Catalog No. 10638819, 10638820, 10638823, 10638824, 10638825,10638826, 10714149,10714159, 10805072, 10805073, 10975000, 10975001, 6000-0008, 6000-0026. Japan: 10638819 LabPro v4.11 Software Update Kit 10638820 LabPro v4.11 System Software…	Device	Class II	1	Terminated
5 Feb 2016	Allegra X-5 rotor yoke, Catalog No. (Instruments) B30589 and B30590 (Rotor) B30593. Product Labeling: IFU B29071AA. Product Usage: For In Vitro Diagnostic Use. The Allegra X-5 is intended for the separation of components through the use of relative centrifugal force. It is designed to separate human samples,…	Device	Class II	1	Terminated
13 Jan 2016	iChem VELOCITY Automated Urine Chemistry, Catalog No. 800-3049, 800-3050, 800-3079, 800-3080, 800-3530, 800-7167, 800-7190, 800-7713, 800-7714, 800-7719, 800-7720 iChem VELOCITY Urine Chemistry Strips, Catalog No. 800-7212 & 800-7212-001	Device	Class II	1	Terminated
1 Dec 2015	UniCel DxH 800 Coulter Cellular Analysis System, Software Version 3.0.2.0, Part No. 629029, B24465, B24802 The UniCel DxH 800/DxH 600 analyzers are quantitative, multi-parameter, automated hematology analyzers for in vitro diagnostic use in screening patient populations found in clinical laboratories. The DxH 800 is…	Device	Class II	3	Terminated
1 Dec 2015	MicroScan Pos Combo Panel Type 21, Part No. B1017-201 MicroScan Pos (Positive) panels are designed for use in determining antimicrobial agent susceptibility and/or identification to the species level of rapidly growing aerobic and facultative gram-positive cocci, some fastidious aerobic gram-positive cocci and…	Device	Class II	5	Terminated
13 Oct 2015	Access CEA Assay, Part No. 33200. For the quantitative determination of Carcinoembryonic Antigen (CEA) levels in human serum.	Device	Class II	1	Terminated
10 Sep 2015	MICroSTREP plus 1 Panel, Part No. B1027-201 Product Usage: MicroScan MICroSTREP plus panels are designed for use in determining quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of aerobic streptococci, including Streptococcus pneumoniae.	Device	Class II	2	Terminated
31 Aug 2015	Access Free T3 Reagent Kit, P/N A13422 The Access Free T3 assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of free triiodothyronine levels in human serum and plasma using the Access Immunoassay Systems.	Device	Class II	1	Terminated
30 Jul 2015	AU480 Chemistry Analyzers, Reference No. B28624 The AU series are automated, clinical chemistry analyzers that measure analytes in patient samples (serum, plasma, urine, CSF) in combination with appropriate reagents, calibrators, quality, control (QC) materials, and other accessories.	Device	Class II	3	Terminated
28 Jul 2015	Access Thyroglobulin Assay; 100 determinations, 2 packs, 50 tests/pack. For the quantitative determination of thyroglobulin levels in human serum and plasma using the Access Immunoassay Systems.	Device	Class II	1	Terminated
22 Jul 2015	COULTER LH Series Diluent, Catalog No. 8547194, Product Labeling A40192-AD. The diluent provides the ability to analyze portions of the diluted blood sample for different blood cell types, such as red blood cells and platelets.	Device	Class II	2	Terminated
17 Jul 2015	MicroScan LabPro Information Manager System, Version 1.0 to Version 4.11, Catalog No. 10714149, 10714150. Intended to manage both microbial identification (ID) and antimicrobial agent susceptibility testing (AST).	Device	Class II	1	Terminated
13 Apr 2015	COULTER DxH Diluent, Catalog No. 628017, Part No. A59956. For use as an isotonic buffered diluent in conjunction with a cyanide-free lytic agent for counting and sizing blood cells.	Device	Class II	1	Terminated
15 Dec 2014	Beckman Coulter, Lipase Assay, Catalog No. OSR6X30	Device	Class II	4	Terminated
8 Dec 2014	iChem 10 SG Urine Chemistry Strips, PN 800-7005. Intended for the in vitro measurement of glucose, protein, bilirubin, urobilinogen, pH, specific gravity, blood, ketones, nitrite, leukocyte esterase, ascorbic acid, and color.	Device	Class II	1	Terminated
6 Oct 2014	Access 2 Immunoassay Systems, Catalog No. 81600N, 386220, Instructions for Use Part No. B14253A. Product Usage: The Access 2 Immunoassay system is an in vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body fluids.	Device	Class II	2	Terminated
25 Aug 2014	Coulter DxH Diluent, Catalog No. 628017 Blood cell analysis comprises diluting a whole-blood sample with a solution that functions as a diluent. The diluent provides the ability to analyze portions of the diluted blood sample for different blood cell types and the measurement of hemoglobin.	Device	Class II	1	Terminated
21 Aug 2014	UniCel 600/800 Access Immunoassay Systems are in vitro diagnostic devices used for the quantitative, semi-quantitative, or qualitative determination of various analytes concentrations found in human body fluids. The cables and kits are used in UniCel DxI 600, 800 instruments, and are distributed to Beckman and…	Device	Class II	1	Terminated
8 Aug 2014	MicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels Containing Lower Imipenem Dilutions for Reporting CLSI M100-S20 Breakpoints Panel: Neg Combo 50, Catalog B1017-406 Microbiology: For use with MicroScan Dried Gram Negative MIC/Combo Panels and Dried Gram Negative Breakpoint Combo Panels. MicroScan…	Device	Class II	7	Terminated
14 May 2014	Ultrasonic Transducer Kits For use with the Access Family of Immunoassay Systems. The Access Family of Immunoassay Systems includes the Access 2, UniCel DxI 800 and UniCel DxI 600, UniCel DxC 600i, and the UniCel DxC 880i, UniCel DxC 860i, UniCel DxC 680i, and UniCel DxC 660i systems.	Device	Class II	1	Terminated
14 May 2014	MicroScan -Neg Breakpoint Combo Panel Type 34; Catalog number B1017-404; Panel MicroScan Neg Breakpoint 34 Neg panels are designed for use in determining quantitative and /or qualitative antimicrobial agent susceptibility and /or identification to No.1 the species level of colonies, grown 34 on solid media, of…	Device	Class II	1	Terminated
22 Apr 2014	UniCel DxC Synchron Clinical Systems and UniCel DxC Synchron Access Integrated Clinical Systems The affected part is Part number 70300. Part number 970300 is used to transfer No Foam Solution from the No Foam Bottle to the Waste B canister and the Waste Manifold on the DxC Hydro System. Catalog No. UniCel DxC 800…	Device	Class II	1	Terminated
8 Apr 2014	MicroScan Pos Combo Panel Type 33 (PC33): Catalog number B1017-211 MicroScan Pos Combo 33 B1017-211 panels are designed for use in determining quantitative and /or qualitative antimicrobial agent susceptibility and/or identification to the species level of colonies, grown on solid media, of rapidly growing aerobic…	Device	Class II	1	Terminated
26 Nov 2013	Access 2 Immunoassay System Analyzer. The Access Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids.	Device	Class II	2	Terminated
8 Nov 2013	UniCel DxH 800 Coulter Cellular Analysis System, Part No. 629029, B24465, and B24802. Used for in vitro diagnostic use in screening patient populations found in clinical laboratories.	Device	Class II	4	Terminated
8 Nov 2013	Coulter LH 750 Hematology Analyzer, Part No. 6605632, A85570 Product Usage: The Coulter LH 750 Hematology Analyzer is a quantitative, automated hematology analyzer and leukocyte differential counter For In Vitro Diagnostic Use in clinical laboratories. The Coulter¿ LH 750 Hematology Analyzer provides automated…	Device	Class II	2	Terminated
2 Oct 2013	Access Immunoassay Systems Reaction Vessels. The Access Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids.	Device	Class II	1	Terminated
24 Sep 2013	COULTER LH 750 and LH 780 Analyzers. The COULTER LH 750 Hematology Analyzer is a quantitative, automated hematology analyzer and leukocyte differential counter For In Vitro Diagnostic Use in clinical laboratories. The COULTER LH 750 Hematology Analyzer provides automated Reticulocyte analysis and enumeration of…	Device	Class II	1	Terminated
24 Sep 2013	UniCel DxH 800 and DxH 600 Coulter Cellular Analysis Systems The UniCel DxH 800/DxH 600 analyzers are quantitative, multiparameter, automated hematology analyzers for in vitro diagnostic use in screening patient populations found in clinical laboratories. The DxH 800 is available as an analyzer for use on a tabletop…	Device	Class II	1	Terminated
12 Sep 2013	Access 2 Immunoassay System, Part Number: 81600N The Access Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids.	Device	Class II	1	Terminated
9 Sep 2013	ISE REF Valve, Part No. MU3226 for the AU400, AU640, AU2700, and AU5400 Chemistry Analyzer. Automated chemistry analyzers that measures analytes in samples.	Device	Class II	2	Terminated
17 Jul 2013	Hemoccult ICT (Immunochemical Fecal Occult Blood Test) is a rapid, visually read, qualitative immunochemical chromatographic method for detection of human hemoglobin in fecal samples.	Device	Class II	1	Terminated
3 Jun 2013	AU5800 Clinical Chemistry Analyzer with Automation Ready Connection (All Software Versions), Model Numbers AU5811, AU5821, AU5831 and AU5841. This system is for in vitro diagnostic use only.	Device	Class II	1	Terminated
28 May 2013	SYNCHRON System(s) Lactate (LACT) Reagent. Product Usage: Lactate (LACT) reagent, when used in conjunction with Synchron LX¿ System(s), UniCel¿ DxC 600/800 System(s) and Synchron¿ Systems Multi Calibrator, is intended for the quantitative determination of lactate concentration in human plasma and cerebrospinal fluid…	Device	Class II	1	Terminated
26 Apr 2013	AU2700 Clinical Chemistry Analyzer AU5400 Clinical Chemistry Analyzer Perform automated analysis of serum, urine, and other body fluids, including whole blood.	Device	Class II	1	Terminated
17 Apr 2013	Synchron LX System(s) and UniCel DxC 600/800 System(s) Lactate Reagent, Part Number: A95550 Product Usage: Lactate (LACT) reagent, when used in conjunction with Synchron LX System(s), UniCel DxC 600/800 System(s) and Synchron Systems Multi Calibrator, is intended for the quantitative determination of lactate…	Device	Class II	1	Terminated
20 Mar 2013	AU5800 Clinical Chemistry Analyzer The Beckman Coulter AU5800 Clinical Chemistry Analyzer is an automated chemistry analyzer that measures analytes in samples, in combination with appropriate reagents, calibrators, quality control (QC) material and other accessories. This system is for in vitro diagnostic use only.…	Device	Class II	1	Terminated
12 Feb 2013	Access Immunoassay System; P/N 107405S Product Usage: The Access Immunoassay Systems are in vitro diagnostic devices used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids.	Device	Class II	4	Terminated
28 Dec 2012	Creatinine, Part Numbers OSR6178, OSR6678 Product Usage: System reagent for the quantitative determination of Creatinine in human serum and urine on Beckman Coulter AU analyzers.	Device	Class II	1	Terminated
28 Nov 2012	Beckman Coulter AU5800 Clinical Chemistry Analyzer. An automated chemistry analyzer that measures analytes such as Glucose, Magnesium, and Potassium.	Device	Class II	1	Terminated
5 Nov 2012	The Access hLH assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of luteinizing hormone (LH) levels in human serum and plasma using the Access Immunoassay Systems. The Access hLH Calibrators are intended to calibrate the Access hLH assay for the quantitative…	Device	Class II	1	Terminated
1 Nov 2012	Access Immunoassay System, Access 2 Immunoassay System, Synchron LXi 725 Clinical System, UniCel DxC 600i Synchron Access Clinical System Part Numbers: Access 81600; Access 2 81600N, 386220, A69186, A25656, A12900; Access 2 (LXi) A15642; Access 2 Section, DxC 600i A25640. The Access Immunoassay System is an…	Device	Class II	1	Terminated
26 Oct 2012	Beckman Coulter AU5800 Clinical Chemistry Analyzer, All Serial Numbers. An automated chemistry analyzer that measures analytes in samples, in combination with appropriate reagents, calibrators, quality control (QC), material and other accessories.	Device	Class II	1	Terminated

Showing the 200 most recent of 216 events.

By type and class

Device216

Class II207

Class III7

Class I2

Class I: 1% of this firm's events; 18% of all events on the register.

Events by year

Enforcement events for Beckman Coulter Inc. by year initiated.

Questions and answers

How many FDA recalls has Beckman Coulter Inc. had?

216 enforcement events (334 product records) on this register, 2010–2026: 216 device.

Are any Beckman Coulter Inc. recalls ongoing?

79 events are listed as ongoing in the current openFDA export.

What class are Beckman Coulter Inc. recalls?

207 Class II, 7 Class III, 2 Class I. 1% are Class I against 18% of all events on the register. Class reflects the relative degree of health hazard of the product, not the firm.

Where does this data come from?

openFDA food, drug and device enforcement reports (CC0), export dated 28 Sep 2026.

Provenance

Source: openFDA enforcement reports (CC0), export dated 28 Sep 2026. Firm names are grouped exactly as FDA spells them; the same company can appear under several spellings. Only organisations are shown. See the methodology.