Food, drugs, devices › Beckman Coulter Inc.

Device recall: Access Thyroglobulin Assay; 100 determinations, 2 packs, 50 tests/pack. For the quantitative determination of thyroglobu

Q: Why was this device recalled?

FDA's record gives the reason for recall as: "Beckman Coulter, Inc. is recalling Access Thyroglobulin reagent packs because some may exhibit greater than 10% imprecision at concentrations <10 ng/mL."

Q: What does Class II mean?

FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

Q: Where was the product distributed?

FDA's distribution pattern field reads: "Worldwide Distribution-US (nationwide) including Puerto Rico and the countries of Algeria, Australia, Austria, Belgium, Bolivia, Brazil, Bulgaria, Canada, Chile, China, Colombia, Czech Republic,…"

Q: Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 13 Apr 2016. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.

Q: Where does this data come from?

openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.

FDA enforcement event 71878 · Class II · initiated 28 Jul 2015 · status Terminated · terminated 13 Apr 2016

DeviceVoluntary: Firm initiated1 product recordBrea, CA

Beckman Coulter Inc. (Brea, CA) initiated this device recall on 28 Jul 2015; FDA lists 1 product record under event 71878, classified Class II.

FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 91% of the 1,153 device enforcement events initiated in 2015 carry the same class.

Status: Terminated, terminated 13 Apr 2016. Initiation: voluntary: firm initiated. Beckman Coulter Inc. has 216 enforcement events on this register, with a median of 1 product record per event.

Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.

Recalling firm

Beckman Coulter Inc., Brea, CA.

Reason for recall

"Beckman Coulter, Inc. is recalling Access Thyroglobulin reagent packs because some may exhibit greater than 10% imprecision at concentrations <10 ng/mL."

Distribution

"Worldwide Distribution-US (nationwide) including Puerto Rico and the countries of Algeria, Australia, Austria, Belgium, Bolivia, Brazil, Bulgaria, Canada, Chile, China, Colombia, Czech Republic,…"

Product records

Recall number	Product	Quantity	Class	Status	Report date
Z-2733-2015	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.	3,035 (U.S.) and 7,123 (International)	Class II	Terminated	9 Sep 2015

Context

91%of 2015 device events are Class II1,153 events that year

1product record in this eventfirm median: 1

216events on this register for the firm

Other enforcement events for Beckman Coulter Inc.

Initiated	Product (first record)	Type	Class	Records
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	Device	Class II	2
26 Jun 2026	REF # D23352, MicroScan LabPro V5.03 Panel Update 11 (US), Electronic installed on the following instruments: - B1018-28	Device	Class II	2
16 Mar 2026	Access Total T4 Calibrator, Catalog No. 33805	Device	Class II	1
23 Dec 2025	CellMek SPS Sample Preparation System, REF: C44603, with software	Device	Class II	1
26 Nov 2025	Beckman Coulter UniCel Dxl 600, Part numbers: A71460, A71461, A30260; Immunoassay Method, Troponin Subunit	Device	Class II	2
10 Nov 2025	COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For use as an isotonic buffered diluent in conjunctio	Device	Class II	1
7 Nov 2025	Access 2 Reaction Vessels, individual, disposable, plastic tubes used to process patient, quality control and calibratio	Device	Class II	1
1 Oct 2025	Beckman Coulter UniCel DxI 600, Part Numbers: A71460, A30260; Photometric Chemistry Analyzer	Device	Class II	2
22 Sep 2025	DxFLEX Flow Cytometer Catalog Number C78500 UDI-DI code: 15099590754013 The DxFLEX Flow Cytometer is intended for use as	Device	Class II	1
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	Device	Class II	2

All 216 events for Beckman Coulter Inc.

Questions and answers

Why was this device recalled?

FDA's record gives the reason for recall as: "Beckman Coulter, Inc. is recalling Access Thyroglobulin reagent packs because some may exhibit greater than 10% imprecision at concentrations <10 ng/mL."

What does Class II mean?

FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

Where was the product distributed?

FDA's distribution pattern field reads: "Worldwide Distribution-US (nationwide) including Puerto Rico and the countries of Algeria, Australia, Austria, Belgium, Bolivia, Brazil, Bulgaria, Canada, Chile, China, Colombia, Czech Republic,…"

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 13 Apr 2016. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.

Where does this data come from?

openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.

Provenance

Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.