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.

101–124 of 124

  • LowFDA (Devices)·Z-1360-2019·2019-05-22

    Abbott Troponin-I Calibrators Recalled for Missing Dry Ice Packaging

    Abbott Laboratories is recalling ARCHITECT STAT High Sensitive Troponin-I Calibrators because they were delivered without the required dry ice.

    Product
    ARCHITECT STAT High Sensitive Troponin-I Calibrators - 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
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-1363-2019·2019-05-22

    Abbott Technopath Multichem S Plus Level 2 Recalled for Missing Dry Ice

    Abbott Laboratories is recalling Technopath Multichem S Plus Level 2 quality control serum delivered to Latvia without required dry ice.

    Product
    Technopath Multichem S Plus Level 2 - 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-1361-2019·2019-05-22

    Abbott Recalls Alinity i Anti-TPO Calibrators Due to Missing Dry Ice

    Abbott Laboratories is recalling Alinity i Anti-TPO Calibrators in Latvia because they were delivered without required dry ice.

    Product
    ALINITY i Anti-TPO Calibrators - Product Usage: The Alinity i Anti-TPO Calibrators are for the calibration of the Alinity i analyzer when used for the quantitative determination of the IgG class of thyroid peroxidase autoantibodies (anti-TPO) in human serum and plasma.
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-1358-2019·2019-05-22

    Abbott Recalls ARCHITECT Intact PTH Calibrators Due to Missing Dry Ice

    Abbott Laboratories is recalling two units of ARCHITECT Intact PTH Calibrators because they were delivered without the required dry ice.

    Product
    ARCHITECT Intact PTH Calibrators - 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
  • ModerateFDA (Devices)·Z-1074-2019·2019-04-10

    Abbott Recalls CELL-DYN Emerald Analyzers Due to Quality Control Errors

    Abbott Laboratories is recalling 6,353 CELL-DYN Emerald analyzers worldwide because they may generate incorrect low quality control results for red blood cells and platelets.

    Product
    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.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2613-2017·2017-06-28

    Abbott Recalls ARCHITECT SHBG Reagent Due to Specimen Tube Interference

    Abbott Laboratories is recalling 7,981 kits of ARCHITECT SHBG Reagent because using Potassium EDTA specimen tubes may cause falsely decreased test results.

    Product
    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 th
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1438-2017·2017-03-15

    Abbott Recalls CELL-DYN Ruby Hematology Analyzers Due to Pump Relay Failure

    Abbott Laboratories is recalling 116 CELL-DYN Ruby hematology analyzers because the Pump Relay PCBA may prematurely fail, causing the instrument to stop working.

    Product
    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
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0379-2017·2016-11-16

    Abbott Recalls Architect Lactic Acid Assay Due to Drug Interference

    Abbott is recalling 26,837 kits of the ARCHITECT Lactic Acid assay because the drug N-Acetyl Cysteine causes negative interference with the reagent.

    Product
    ARCHITECT Lactic Acid Part # 09D891T21 The Lactic Acid assay is used for the quantitation of lactic acid in human plasma.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1865-2016·2016-06-08

    Abbott ARCHITECT Estradiol Kit Recalled for Fulvestrant Interference

    Abbott Laboratories is recalling ARCHITECT Estradiol Kits because interaction with the drug Fulvestrant causes falsely elevated estradiol results.

    Product
    The ARCHITECT Estradiol Kit Intended to measure estradiol, an estrogenic steroid, in plasma.
    Category
    Medical Device
    Distribution
    42 states
  • ModerateFDA (Devices)·Z-1522-2016·2016-04-27

    Abbott Recalls CELL-DYN Emerald Cleaner Due to Analyzer Quality Control Issues

    Abbott Laboratories is recalling CELL-DYN Emerald Cleaner because it may cause the hematology analyzer to generate out-of-range quality control results for RBC and PLT.

    Product
    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
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2202-2015·2015-07-29

    Abbott ARCHITECT c8000 System Recalled for Tubing Leak Risk

    Abbott Laboratories is recalling five ARCHITECT c8000 systems because the tubing may not meet specifications and could leak.

    Product
    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.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1932-2015·2015-07-08

    Abbott ICT Serum Calibrator Recalled for Inaccurate Potassium Results

    Abbott Laboratories is recalling ICT Serum Calibrator REF 146-03 because it may generate lower than expected Potassium results on the Abbott Architect cSystem.

    Product
    ICT Serum Calibrator REF 146-03. For use in the calibration of the serum Sodium, Potassium, and Chloride assays.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1725-2015·2015-06-17

    Abbott Alkaline Wash Recall Due to Cap Leaking and Crystallization

    Abbott Laboratories is recalling Alkaline Wash cleaning solution for Abbott Architect analyzers due to product leaking from the cap and crystallization around the cap.

    Product
    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.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1409-2015·2015-03-18

    Similac Advance Infant Formula Recalled for Chinese Labeling

    Abbott Laboratories is recalling Similac Advance infant formula because export-bound product with Chinese labeling was distributed in the US.

    Product
    Similac¿ Advance Complete Nutrition Infant Formula with Iron, 1.45lb plastic container.
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0135-2015·2014-11-05

    Abbott HbA1c Calibrators Recalled for Potential Incorrect Value Sheets

    Abbott Laboratories is recalling HbA1c Calibrators that may contain value sheets for a different lot, which could cause falsely elevated test results.

    Product
    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: O
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1672-2014·2014-06-04

    Abbott Recalls ARCHITECT Intact PTH Controls Due to Performance Shift

    Abbott is recalling ARCHITECT Intact PTH Controls because a performance shift may cause falsely elevated results on patient samples.

    Product
    ARCHITECT Intact PTH Controls consists of 3 x 1 Bottle (8.0 mL each) of PTH (synthetic peptide) in Bis Tris Propane buffer with protein (bovine) stabilizer. Preservatives: sodium azide and ProClin 300. Product Usage: The ARCHITECT Intact PTH assay is an in vitro chemiluminesc
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1671-2014·2014-06-04

    Abbott Recalls ARCHITECT Intact PTH Calibrators Due to Performance Shift

    Abbott Laboratories is recalling 7,780 kits of ARCHITECT Intact PTH Calibrators because a performance shift may cause falsely elevated patient results.

    Product
    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
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0698-2013·2013-01-30

    Abbott Vitamin D Reagent Kit Recalled for Inaccurate Test Results

    Abbott Laboratories is recalling ARCHITECT 25-OH Vitamin D Reagent Kits because they may produce falsely elevated or depressed results when used with specific Reaction Vessel lots.

    Product
    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.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-107-2013·2013-01-09

    Abbott Recalls Synthroid Tablets Due to Incorrect Strength Labeling

    Abbott Laboratories is recalling specific lots of Synthroid (levothyroxine sodium) tablets because bottles labeled as 150 mcg actually contained 75 mcg tablets.

    Product
    SYNTHROID — SYNTHROID (LEVOTHYROXINE SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1696-2012·2012-10-03

    Abbott Recalls Synthroid Tablets Due to Defective Bottle Bottoms

    Abbott Laboratories is recalling 40,464 bottles of Synthroid (levothyroxine sodium) 112 mcg tablets nationwide. The recall addresses a localized thin wall defect on the bottom of some bottles that may impact tablet stability.

    Product
    SYNTHROID — SYNTHROID (LEVOTHYROXINE SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1694-2012·2012-10-03

    Abbott Recalls Synthroid Tablets Due to Defective Bottle Bottoms

    Abbott Laboratories is recalling 53,448 bottles of Synthroid (levothyroxine sodium) 50 mcg tablets nationwide due to a defect in the bottle bottom that may affect tablet stability.

    Product
    SYNTHROID — SYNTHROID (LEVOTHYROXINE SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1695-2012·2012-10-03

    Abbott Recalls Synthroid Tablets Due to Container Wall Defect

    Abbott Laboratories is recalling 42,596 bottles of Synthroid (levothyroxine sodium) 75 mcg tablets due to a localized thin wall defect on the bottle bottom that may impact tablet stability.

    Product
    SYNTHROID — SYNTHROID (LEVOTHYROXINE SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1904-2012·2012-07-04

    Abbott Recalls Architect CA 19-9 Reagent Kits Due to Result Shifts

    Abbott Laboratories is recalling specific lots of ARCHITECT CA 19-9XR Reagent Kits because they are causing an upward shift in patient test results.

    Product
    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-
    Category
    Medical Device
    Distribution
    Distributed nationwide

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.