The Recall Desk

Manufacturer

Abbott Laboratories

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

What the numbers show

Total
124
Critical
15
Severe
27
Most recent
2025-12-24

Of the 124 recalls from Abbott Laboratories we have scored against our rubric, 15 (12%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 27 (22%) are Severe.

Which agencies issued them

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.

76–100 of 124

  • SevereFDA (Food)·F-0952-2022·2022-03-16

    Abbott EleCare Jr Amino Acid Powder Recalled for Pathogenic Bacteria

    Abbott EleCare Jr Amino Acid-Based Nutrition Powder (banana) is recalled due to consumer complaints of Cronobacter sakazakii or Salmonella Newport in infants, with pathogen evidence in the manufacturing facility.

    Product
    Abbott EleCare Jr Amino Acid-Based Nutrition Powder Banana 14.1oz. can. 6 cans per case. Item numbers: 66275 Retail UPCs: 070074662763
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0957-2022·2022-03-16

    Abbott Infant Formula Powder Recalled for Bacterial Contamination

    Abbott Laboratories is recalling infant formula powder due to potential contamination with Cronobacter sakazakii and Salmonella Newport. Consumer complaints related to these pathogens in infants have been reported.

    Product
    Abbott Infant Formula Powder 12.6oz. can. 6 cans per case. Item numbers: Clinical Retail UPCs: N/A - Clinical
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0927-2022·2022-03-16

    Abbott Similac Alimentum Infant Formula Recalled for Bacterial Contamination

    Abbott Laboratories recalls Similac Alimentum Infant Formula with Iron due to potential Cronobacter sakazakii and Salmonella Newport contamination. Consumer complaints related to infections in infants and manufacturing facility contamination prompted the FDA Class I recall.

    Product
    Abbott Similac Alimentum Infant Formula with Iron 12oz. can. 6 jars per case; 19.8oz. can. 4 cans per case; 7oz. can. 6 cans per case Item numbers: 64715 64717 64719 Retail UPCs: 070074647128 070074647166 070074647180
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0929-2022·2022-03-16

    Abbott Similac EleCare infant formula recalled for pathogen contamination

    Abbott is recalling approximately 95,077 cases of Similac EleCare infant formula due to consumer complaints involving Cronobacter sakazakii and Salmonella Newport in infants, and detection of Cronobacter sakazakii in the manufacturing facility.

    Product
    Abbott Similac EleCare HMO, Abbott Similac EleCare, Abbott EleCare Similac Gold, Abbott EleCare Similac 400g can. 6 cans per case Item numbers: 6676006 6676012 6676021 6676025 6676030 6676045 6676053 6676057 Retail UPCs: 8699548995217 0070074124155 007007412385
    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
    50 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
    50 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-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-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-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
  • 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
  • ModerateFDA (Devices)·Z-2251-2020·2020-06-10

    Abbott Accelerator APS Aliquoter Module Recalled for Sample Dilution Risk

    Abbott is recalling 11 Accelerator APS Aliquoter Modules because a clot detection error may cause distilled water to dilute samples, leading to incorrect clinical results.

    Product
    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 a
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1895-2020·2020-05-13

    Abbott Recalls C Peptide Calibrator Due to Mexico License Documentation Error

    Abbott Laboratories is recalling 65 kits of ARCHITECT C Peptide Calibrator in Mexico due to an error in the license renewal documentation process.

    Product
    ARCHITECT C Peptide Calibrator - Product Usage: used as an aid in the diagnosis and treatment of patients with abnormal insulin secretion including diabetes mellitus.
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-1894-2020·2020-05-13

    Abbott Recalls C Peptide Calibrators Due to Mexico License Documentation Error

    Abbott Laboratories is recalling 65 kits of ARCHITECT C Peptide Calibrators distributed in Mexico due to an error in the renewal documentation process for the local license.

    Product
    ARCHITECT C Peptide Calibrator - Product Usage: used as an aid in the diagnosis and treatment of patients with abnormal insulin secretion including diabetes mellitus.
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-1893-2020·2020-05-13

    Abbott Recalls Architect C Peptide Reagents Due to Licensing Error

    Abbott Laboratories is recalling 65 kits of ARCHITECT C Peptide Reagents in Mexico due to an error in the license renewal documentation process.

    Product
    ARCHITECT C Peptide Reagent - Product Usage: used as an aid in the diagnosis and treatment of patients with abnormal insulin secretion including diabetes mellitus.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1688-2020·2020-04-15

    Abbott Recalls Hemoglobin A1c Calibrators Due to Potential Test Bias

    Abbott Laboratories is recalling 198 kits of Hemoglobin A1c Calibrators because a manufacturing defect may cause biased patient test results outside a specific concentration range.

    Product
    "HEMOGLOBIN A1c CALIBRATORS *** REF 4P52-01 *** 307261/R03 *** S4P5X0 *** FOR USE WITH ARCHITECT" - Product Usage: use in the calibration of the Hemoglobin A1c assay.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0173-2020·2019-10-30

    Abbott Recalls Emerald Diluent Tubing Due to Cloudiness and Film

    Abbott Laboratories is recalling 22 CELL-DYN Emerald analyzers with diluent tubing that appears cloudy or has a film, which may cause falsely elevated platelet results.

    Product
    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.
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Food)·F-0022-2020·2019-10-16

    Abbott Calcilo XD Infant Formula Recalled for Compromised Can Seams

    Abbott Laboratories is recalling 2,922 cans of Calcilo XD infant formula due to off color, odor, and compromised can seams that may allow air entry.

    Product
    Abbott Calcilo XD, Low-calcium Vitamin D-Free Infant formula with iron, powder in a 13.2 oz. can, with 6 cans per case.
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2078-2019·2019-07-31

    Abbott Recalls ARCHITECT BNP Calibrators Due to Stability Drift

    Abbott Laboratories is recalling 5,483 units of ARCHITECT BNP Calibrators worldwide due to a time-dependent stability drift that affects patient and control test results.

    Product
    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.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2079-2019·2019-07-31

    Abbott Recalls ARCHITECT BNP Controls Due to Stability Drift

    Abbott Laboratories is recalling ARCHITECT BNP Controls because of a time-dependent stability drift that affects test results.

    Product
    ARCHITECT BNP Controls Ptoduct Usage: The ARCHITECT BNP Controls are for the estimation of test precision and the detection of systematic analytical deviations of the ARCHITECT iSystem (reagents, calibrators and instrument), when used for the quantitative determination of h
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1355-2019·2019-05-22

    Abbott Recalls ARCHITECT Sirolimus Calibrators Shipped Without Dry Ice

    Abbott Laboratories is recalling ARCHITECT Sirolimus Calibrators in Latvia because they were delivered without the required dry ice.

    Product
    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.
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-1359-2019·2019-05-22

    Abbott Troponin-I Controls Recalled for Missing Dry Ice

    Abbott Laboratories is recalling ARCHITECT STAT High Sensitive Troponin-I Controls delivered without required dry ice to Latvia.

    Product
    ARCHITECT STAT High Sensitive Troponin-I Controls - Product Usage: The ARCHITECT STAT High Sensitive Troponin-I Controls are for the estimation of test precision and the detection of systematic analytical deviations of the ARCHITECT i System with STAT protocol capability when use
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-1362-2019·2019-05-22

    Abbott Multichem S Plus Quality Control Serum Recalled for Missing Dry Ice

    Abbott Laboratories is recalling Technopath Multichem S Plus Level 1 quality control serum because units were delivered without required dry ice.

    Product
    Technopath Multichem S Plus Level 1 - Product Usage: Multichem S Plus (Assayed) is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in the package insert.
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-1356-2019·2019-05-22

    Abbott Recalls ARCHITECT HbA1C Calibrators Shipped Without Dry Ice

    Abbott Laboratories is recalling ARCHITECT HbA1C Calibrators in Latvia because they were delivered without the required dry ice.

    Product
    ARCHITECT HbA1C Calibrators - Product Usage: The ARCHITECT HbA1c Calibrators are for the calibration of the ARCHITECT i System when used for the quantitative determination of percent hemoglobin A1c (HbA1c) in human whole blood.
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-1357-2019·2019-05-22

    Abbott Recalls ARCHITECT Intact PTH Controls Due to Missing Dry Ice

    Abbott Laboratories is recalling ARCHITECT Intact PTH Controls because they were delivered without required dry ice. The recall affects units distributed to Latvia.

    Product
    ARCHITECT Intact PTH Controls - Product Usage: The ARCHITECT Intact PTH Calibrators are for the calibration of the ARCHITECT iSystem when used for the quantitative determination of Intact PTH in human serum and plasma.
    Category
    Medical Device
    Distribution
    0 states

About this company

Community-sourced company facts from Wikidata, not from any recall agency. This is background on the corporate entity — it says nothing about the recall(s) listed on this page, which come from the agency source notice above.

Abbott Laboratories

American global health care and medical device products company

Country
United States
Founded
1888

Official website

Source: Wikidata (Q306764), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.