Manufacturer

Abbott Laboratories

86 recalls in our database name Abbott Laboratories as the manufacturing or recalling firm.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

76–86 of 86

SevereFDA (Food)·F-0931-2022·2022-03-16
Abbott Similac Pro-Advance Infant Formula recalled for bacterial contamination
Abbott Similac Pro-Advance Infant Formula is being recalled due to potential Cronobacter sakazakii and Salmonella Newport contamination. The FDA Class I recall affects approximately 1.7 million cases distributed nationwide and worldwide.
Product
Abbott Similac Pro-Advance Infant Formula with Iron 20.6oz. and 23.2oz. plastic jar. 4 jars per case; 34oz. plastic jar. 6 jars per case; 7oz. can. 6 cans per case. Item numbers: 66081 66655 67922 68088 Retail UPCs: 070074660806 070074666563 070074679167 070074680
Category
Food
Distribution
Distributed nationwide
SevereFDA (Food)·F-0948-2022·2022-03-16
Abbott infant formula recalled due to bacterial contamination
Abbott Laboratories is recalling EleCare and Similac EleCare infant formula due to consumer complaints of Cronobacter sakazakii and Salmonella Newport infections in infants, and Cronobacter contamination in the manufacturing facility.
Product
Abbott EleCare, EleCare LCP Hypoallergenic, Similac EleCare 400g. can. 6 cans per case. Item numbers: 5351034 5351066 5351039 5351077 Retail UPCs: 17703186031461 9340104000706 17501033957748 070074119281
Category
Food
Distribution
Distributed nationwide
SevereFDA (Food)·F-0939-2022·2022-03-16
Abbott Similac Total Comfort Infant Formula Recalled for Cronobacter and Salmonella
Abbott Similac Total Comfort Infant Formula with Iron is being recalled due to consumer complaints related to Cronobacter sakazakii and Salmonella Newport. The FDA classified this Class I recall affecting over 1.2 million cases.
Product
Abbott Similac Total Comfort Infant Formula with Iron 12.6oz. can. 6 cans per case. Item numbers: 62599 Retail UPCs: 070074626000
Category
Food
Distribution
Distributed nationwide
SevereFDA (Food)·F-0923-2022·2022-03-16
Abbott Similac For Spit Up Infant Formula recalled for pathogenic bacterial contamination
Abbott Laboratories is recalling Similac For Spit Up Infant Formula nationwide and worldwide due to potential contamination with Cronobacter sakazakii and Salmonella Newport. The pathogens were identified through consumer complaints and detected in the manufacturing facility.
Product
Abbott Similac For Spit Up Infant Formula with Iron 22.5oz plastic jar. 6 jars per case. Item numbers: 5372976 Retail UPCs: 070074537306
Category
Food
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0271-2022·2021-12-01
Abbott ARCHITECT Analyzer Software Issues May Cause Inaccurate Test Results
Abbott is recalling approximately 20,994 ARCHITECT i1000SR, i2000SR, and i2000 automated analyzers due to 12 software-related issues in version 9.41 and earlier that may produce inaccurate diagnostic test results.
Product
ARCHITECT i1000SR REF 01L86-01/1L86 and 1L87; ARCHITECT i2000SR REF 03M74-02/3M74; ARCHITECT i2000 REF 08C89-01/1G17 and 8C89
Category
Medical Device
Distribution
49 states
HighFDA (Devices)·Z-0272-2022·2021-12-01
Clinical Chemistry Analyzer Software Defects May Produce Inaccurate Results
Abbott ARCHITECT clinical chemistry analyzers with software 9.41 and earlier contain defects affecting calibration, sample handling, and quality control that may produce inaccurate diagnostic results.
Product
ARCHITECT c4000 REF 02P24-01/2P24, 1P86, 1R24, and 1R25; ARCHITECT c8000 REF 01G06-11/1G06; ARCHITECT c16000 REF 03L77-01/3L77;
Category
Medical Device
Distribution
49 states
HighFDA (Devices)·Z-2472-2021·2021-09-22
Alinity ci-series System Control Module Software Performance Issues
Abbott's Alinity ci-series analyzers with software version 3.2.3 and earlier have multiple issues that could display expired reagents as valid, fail to alert operators to errors, and produce incorrect test results.
Product
Alinity ci-series System Control Module clinical chemistry and immunoassay analyzer for in vitro diagnostic use. Model number LN 03R70-01
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2185-2021·2021-08-11
Abbott Activated Alanine Aminotransferase Reagent Recalled for Inaccurate Test Results
Abbott is recalling 1,603 units of its Activated Alanine Aminotransferase (A-ALT) lab reagent due to potential inaccuracies in test results. High bilirubin or high A-ALT samples may produce incorrect results affecting patient care.
Product
REF 8L92-22, Abbott Activated Alanine aminotransferase, for use with Architect, IVD, CE, UDI: (01) 00380740161859
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2184-2021·2021-08-11
Abbott Alinity c Reagent Kit Recall Due to Potential Test Result Errors
Abbott Laboratories is recalling its Alinity c Activated Alanine Aminotransferase reagent kit due to potential analytical errors that could produce incorrect test results. The issue affects certain lot numbers distributed worldwide.
Product
REF: 08P1820, Abbott Alinity c Activated Alanine Aminotransferase reagent Kit, Alinity c Activated Alanine Aminotransferase Reagent Kit,, IVD, CE, UDI: (01) 00380740132569
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2187-2021·2021-08-11
Abbott Activated Alanine Aminotransferase Reagent May Produce Inaccurate Patient Results
Abbott's A-ALT diagnostic reagent may produce inaccurate test results for samples with elevated enzyme or bilirubin levels, potentially affecting patient outcomes. The affected reagent kits have been distributed worldwide.
Product
REF 8L92-42, Abbott Activated Alanine Aminotransferase, for use with Architect, IVD, CE, UDI: (01) 00380740161866
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2186-2021·2021-08-11
Abbott Activated Alanine Aminotransferase Reagent Accuracy Issue Recall
Abbott's A-ALT laboratory reagent may produce inaccurate results in samples with very high enzyme levels or elevated bilirubin, potentially affecting patient diagnoses. The affected product (REF 8L92-21) was distributed worldwide.
Product
REF 8L92-21, Abbott Activated Alanine Aminotransferase, for use with Architect, IVD, CE, UDI: (01) 00380740017866
Category
Medical Device
Distribution
Distributed nationwide