Abbott Laboratories

FDA recalling firm · 46 enforcement events · 124 product records · 2012–2025 · IL, TX

Abbott Laboratories has 46 FDA enforcement events on this register (124 product records) between 2012 and 2025: 34 device, 9 food and 3 drug; the busiest year was 2022 with 9.

2% of its events are Class I; the most common class is Class II (40). 16 events are listed as ongoing; the recalling firm's address is in IL and TX.

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
13 Nov 2025	Alinity ci-series System Control Module (SCM), REF: 03R70-01, 03R70-20	Device	Class II	1	Ongoing
18 Sep 2025	Brand Name: Alinity hq Analyzer Product Name: Alinity hq Analyzer Model/Catalog Number: 09P68-01 Software Version: 5.0 to 5.10.1 for OUS, 5.7 and 5.10.1 in the US Product Description: Alinity hq Analyzer Component: No	Device	Class II	1	Ongoing
18 Mar 2025	Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 08H67-01 Software Version: All software versions Product Description: CELL-DYN Ruby Component: No	Device	Class II	5	Ongoing
14 Jun 2024	Alinity hq Analyzer, REF: 09P68-01	Device	Class II	1	Ongoing
21 Feb 2024	ARCHITECT STAT Myoglobin Reagent Kit, LN 2K43-25 and 2K43-20.	Device	Class II	1	Ongoing
31 Oct 2023	Similac Probiotic Tri-Blend - 0.017oz (0.50g) packaged in foil packets. 50 foil packets per carton - 3 cartons per case.	Food	Class II	1	Terminated
19 Oct 2023	Abbott CELL-DYN Ruby, Model CD-Ruby, List number 08H67-01, and Abbott CELL-DYN Sapphire, Model CD Sapphire, list number 08H00-01. Multi-parameter, automated hematology analyzer.	Device	Class II	1	Ongoing
19 Oct 2023	Alinity i Processing Module REF 03R65-01 The Alinity i Processing Module is a fully automated immunoassay analyzer allowing random and continuous access, as well as priority and automated retest processing using chemiluminescent microparticle immunoassay (CMIA) technology. CMIA technology is used to determine the…	Device	Class II	3	Ongoing
30 May 2023	Alinity ci-series System Control Module, REF: 03R70-01	Device	Class II	1	Ongoing
28 Mar 2023	Zone Perfect Fudge Graham bar 50g bars packaged in foil wrapped- 12 bars individually wrapped per cardboard carton	Food	Class II	1	Terminated
24 Nov 2022	Alinity Reaction Vessels, REF: 06P1401, for use with Alinity i Systems; ARCHITECT Reaction Vessels	Device	Class III	1	Ongoing
13 Oct 2022	Pedialyte Unflavored Electrolyte Solution 2 fl oz plastic reclosable bottle 12-4 packs in a case	Food	Class II	12	Terminated
26 Jul 2022	ARCHITECT STAT Troponin-I Reagent Kit, REF 2K41-27	Device	Class II	1	Ongoing
3 Jul 2022	Abbott Jevity Complete, Balanced Nutrition with Fiber Ready to Hang enteral feeding container 1.5 Cal (for tube feeding) 1000 mL 8-33.8 FL OZ (1L) Bottles 270 FL OZ (8L) Liter UPC: 7007462681 62681	Food	Class II	1	Terminated
9 Jun 2022	REF: 4P52-20 Hemoglobin A1c for use with Architect, IVD, CE, R1 1 x 52 mL, R2 1 x 20 mL, A1cDL 2 x 35 mL	Device	Class II	3	Ongoing
3 Jun 2022	Pedialyte with Immune Support*+Zinc/Selenium & MagnesiumPeach Mango Natural & Artificial Flavor, 33.8 FL OZ (1.05 QT) 1LINGREDIENTS: WATER, DEXTROSE* Abbott Nutrition, Abbott Laboratories, Columbus, Ohio 43219-3034 USA	Food	Class II	2	Terminated
3 Jun 2022	Pedialyte*Replaces ElectrolytesGreat for Kids and AdultsStrawberry Lemonade Natural Flavor with Other Natural Flavor* 6 0.6 OZ (17g) PACKETS/NET WT. 3.6 OZ (102g)*INGREDIENTS: ANHYDROUSE DEXTROSE, CITRIC ACID, POTASSIUM CITRATE*Manufactured for: Abbott Nutrition, Abbott Laboratories, Columbus, Ohio 43219	Food	Class III	1	Terminated
8 Mar 2022	ARCHITECT STAT Myoglobin Calibrators, RES 2K43-01 The ARCHITECT STAT Myoglobin Calibrators are for the calibration of the ARCHITECT iSystem with STAT protocol capability when used for the quantitative determination of myoglobin in human serum and plasma.	Device	Class II	1	Ongoing
17 Feb 2022	Abbott EleCare Infant Formula Unflavoured 400g can. 6 cans per case. Item number 5466539 Retail unit UPC 070074104591	Food	Class I	41	Ongoing
29 Sep 2021	ARCHITECT i1000SR REF 01L86-01/1L86 and 1L87; ARCHITECT i2000SR REF 03M74-02/3M74; ARCHITECT i2000 REF 08C89-01/1G17 and 8C89	Device	Class II	2	Ongoing
26 Jul 2021	Alinity ci-series System Control Module clinical chemistry and immunoassay analyzer for in vitro diagnostic use. Model number LN 03R70-01	Device	Class II	1	Ongoing
10 Jun 2021	REF: 08P1820, Abbott Alinity c Activated Alanine Aminotransferase reagent Kit, Alinity c Activated Alanine Aminotransferase Reagent Kit,, IVD, CE, UDI: (01) 00380740132569	Device	Class II	4	Ongoing
2 Apr 2020	Accelerator APS Aliquoter Module, List number: 07L40 - Product Usage: The ACCELERATOR APS Workcell is a modular system designed to automate sample handling and processing in the clinical laboratory. The system allows consolidations of multiple clinical chemistry and immunoassay analytical instruments into a unified…	Device	Class II	1	Terminated
1 Apr 2020	ARCHITECT C Peptide Reagent - Product Usage: used as an aid in the diagnosis and treatment of patients with abnormal insulin secretion including diabetes mellitus.	Device	Class III	3	Terminated
13 Sep 2019	Abbott Calcilo XD, Low-calcium Vitamin D-Free Infant formula with iron, powder in a 13.2 oz. can, with 6 cans per case.	Food	Class II	1	Terminated
24 May 2019	ARCHITECT BNP Calibrators Ptoduct Usage: The ARCHITECT BNP Calibrators are for the calibration of the ARCHITECT iSystem when used for the quantitative determination of human Btype natriuretic peptide (BNP) in human EDTA plasma.	Device	Class III	2	Terminated
22 May 2019	"HEMOGLOBIN A1c CALIBRATORS * REF 4P52-01 * 307261/R03 * S4P5X0 * FOR USE WITH ARCHITECT" - Product Usage: use in the calibration of the Hemoglobin A1c assay.	Device	Class II	1	Terminated
9 May 2019	Emerald Diluent Tubing, List number 09H50-01, accompanying CELL-DYN Emerald instrument, List number 09H39-01. The firm name on the label is Abbott Laboratories, Abbott Park, IL.	Device	Class II	1	Terminated
9 Apr 2019	ARCHITECT Sirolimus Calibrators - Product Usage: The ARCHITECT Sirolimus Calibrators are for the calibration of the ARCHITECT iSystem when used for the quantitative determination of sirolimus in human whole blood.	Device	Class III	9	Terminated
20 Feb 2019	CELL-DYN Emerald analyzer, REF 09H39-01. The CELL-DYN Emerald is an automated hematology analyzer intended for in-vitro diagnostic use in the clinical laboratory.	Device	Class II	1	Terminated
18 Apr 2017	ARCHITECT SHBG Reagent The ARCHITECT SHBG assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of sex hormone binding globulin (SHBG) in human serum and plasma on the ARCHITECT iSystem. The ARCHITECT SHBG assay is used as an aid in the diagnosis of androgen disorders.	Device	Class II	1	Terminated
13 Feb 2017	CELL-DYN Ruby System: List Number: 08H6701; Hematology: The CELL-DYN Ruby System is a multi-parameter automated hematology analyzer designed for in-vitro diagnostic use in clinical laboratories	Device	Class II	1	Terminated
11 Oct 2016	ARCHITECT Lactic Acid Part # 09D891T21 The Lactic Acid assay is used for the quantitation of lactic acid in human plasma.	Device	Class II	1	Terminated
24 Mar 2016	The ARCHITECT Estradiol Kit Intended to measure estradiol, an estrogenic steroid, in plasma.	Device	Class II	1	Terminated
24 Mar 2016	CELL-DYN Emerald Cleaner, product number 09H46-02. 960mL. IVD; Hematology: The CELL-DYN Emerald Cleaner is designed for use on the CELL-DYN Emerald System, which is an automated hematology analyzer designed for in-vitro diagnostic use in clinical laboratories. The CELL-DYN Emerald Cleaner is an enzymatic cleaner used…	Device	Class II	1	Terminated
11 Jun 2015	ARCHITECT c8000 System List Number 01G06-98 Product Usage: The Abbott ARCHITECT cSystem is intended for In Vitro diagnostic use only. It is designed to perform automated: chemistry tests, utilizing photometry and potentiometric technology.	Device	Class II	1	Terminated
11 May 2015	Alkaline Wash, List number 9D31-20, a cleaning solution used by the Abbott Architect analyzers. It is supplied in 500 mL bottles and contains NaOCl, NaOH, and KOH. It is shipped and stored at room temperature and is shipped ready to use.	Device	Class II	1	Terminated
28 Jan 2015	Similac¿ Advance Complete Nutrition Infant Formula with Iron, 1.45lb plastic container.	Food	Class II	1	Terminated
22 Jul 2014	ICT Serum Calibrator REF 146-03. For use in the calibration of the serum Sodium, Potassium, and Chloride assays.	Device	Class II	1	Terminated
30 Apr 2014	HbA1c Calibrators LN 4P52-02 consists of: 4P52-02 Hemoglobin A1c 1 x 1.6 mL and 1 x 1.6 mL. A1c Calibrators (lyophilized) contain hemoglobin and glycated hemoglobin from human whole blood. Prior to lyophilization, the calibrator matrix is an MES-buffered solution. Preservative: Ofloxacin. For use in the calibration…	Device	Class II	1	Terminated
12 Feb 2014	ARCHITECT Intact PTH Calibrators consists of 6 bottles (4.0 mL each). Calibrator A contains Bis Tris Propane buffer with protein (bovine) stabilizer. Calibrators B-F contain PTH (synthetic peptide) in Bis Tris Propane buffer with protein (bovine) stabilizer. Preservatives: sodium azide and ProClin 300. Product Usage:…	Device	Class II	2	Terminated
12 Dec 2012	Abbott Laboratories, ARCHITECT 25-OH Vitamin D Reagent Kit, 03L52-25 (ROW) and 03L52-27 (U.S.) (1 x 100 tests), 03L52-35 (ROW) and 03L52-37 (U.S.) (5 x 100 tests); in vitro diagnostic.	Device	Class II	1	Terminated
4 Dec 2012	Synthroid (Levothyroxine Sodium) tablets, 150 mcg (0.15 mg), 90 tablets per bottle, Rx Only, NDC 0074-7069-90; ABBOTT LABORATORIES NORTH CHICAGO, IL 60064 U.S.A.	Drug	Class II	1	Terminated
19 Jul 2012	Synthroid (levothyroxine sodium) Tablets USP, 50 mcg, Rx Only, 90-Count Bottle, Abbott Laboratories, North Chicago, IL 60064, NDC: 0074-4552-90.	Drug	Class II	3	Terminated
30 May 2012	ARCHITECT CA 19-9XR Reagent Kit; ARCHITECT CA 19-9 Reagent Kit, list 291-20 (4 x 100 tests), 2K91-25 and 2K91-27 (1 x 100 tests); Product Usage: The ARCHITECT CA 19-9XR assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of 1116-NS-19-9 reactive determinants in human serum…	Device	Class II	1	Terminated
14 May 2012	Zemplar (paricalcitol) Injection, 5 mcg/mL in 2 mL multi-dose vials, 25 vial carton, Rx only, Manufactured by Hospira, Inc. For Abbott Laboratories, North Chicago, IL 60064, USA, NDC 0074-1658-05	Drug	Class II	1	Terminated

By type and class

Device34

Food9

Drug3

Class II40

Class III5

Class I1

Class I: 2% of this firm's events; 18% of all events on the register.

Events by year

Enforcement events for Abbott Laboratories by year initiated.

Questions and answers

How many FDA recalls has Abbott Laboratories had?

46 enforcement events (124 product records) on this register, 2012–2025: 34 device, 9 food, 3 drug.

Are any Abbott Laboratories recalls ongoing?

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

What class are Abbott Laboratories recalls?

40 Class II, 5 Class III, 1 Class I. 2% 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.