The Recall Desk

Manufacturer

Abbott Laboratories, Inc.

32 recalls in our database name Abbott Laboratories, Inc. as the manufacturing or recalling firm.

What the numbers show

Total
32
Critical
0
Severe
1
Most recent
2022-03-23

Of the 32 recalls from Abbott Laboratories, Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1 (3%) are Severe.

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.

26–32 of 32

  • ModerateFDA (Devices)·Z-0165-2018·2017-11-29

    Abbott Clinical Chemistry Systems Recalled for Tubing Leak Risk

    Abbott is recalling 34 ARCHITECT c4000, c8000, and c16000 clinical chemistry systems because a manufacturing issue with the peristaltic head tubing may cause leaks.

    Product
    ARCHITECT c4000 part number 02P24; ARCHITECT c8000 part number 01G06; ARCHITECT c16000 part number 03L77 Clinical Chemistry systems.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0011-2018·2017-10-18

    Abbott ARCHITECT c4000 Cuvette Segment Recall for Potential False Results

    Abbott is recalling 1,385 ARCHITECT c4000 cuvette segments because a detached post may cause falsely depressed patient results in adjacent cuvettes.

    Product
    ARCHITECT c4000 Cuvette Segment, List number 02P75-01. The firm name on the label is Abbott Laboratories, Abbott Park, IL. Cuvette segments are a component to the ARCHITECT c4000 system. Cuvette segments are racks that sit in the reaction carousel and hold cuvettes. Each cuv
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0163-2016·2015-11-04

    Abbott Recalls ARCHITECT i2000SR Systems Due to Incorrect Tubing

    Abbott Laboratories is recalling 65 ARCHITECT i2000SR diagnostic systems worldwide because they contain incorrect tubing.

    Product
    ARCHITECT i2000SR System The Abbott ARCHITECT System is intended for In Vitro diagnostic use only. The ARCHITECT system is designed to perform automated immunoassay tests, utilizing CMIA (chemiluminescent microparticle assay) detection technology.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0131-2015·2014-11-05

    Abbott Lipase Reagent Recalled for Incorrect Package Insert Parameters

    Abbott Laboratories is recalling Lipase Reagent 7D80 because package inserts contain incorrect SmartWash parameters for Triglyceride.

    Product
    Lipase Reagent, 7D80. Used to measure lipase in human serum on the Architect system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0020-2014·2013-10-23

    Abbott Clinical Chemistry Phosphorus Reagent Recalled for Incorrect Expiration Dates

    Abbott Laboratories is recalling specific lots of Clinical Chemistry Phosphorus Reagent because the supplier assigned incorrect expiration dates to the product.

    Product
    Clinical Chemistry Phosphorus Reagent The Phosphorus assay is used for the quantitation of phosphorus in human serum, plasma, or urine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1118-2013·2013-04-24

    Abbott Recalls Phenobarbital Reagent Lots Due to Imprecision Issues

    Abbott Diagnostics is recalling Clinical Chemistry Phenobarbital reagent lots due to imprecision issues that increase with the age of the reagent.

    Product
    Clinical Chemistry Phenobarbital, list number 1E08
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0987-2013·2013-04-03

    Abbott Recalls ARCHITECT HBsAg Assay Files Due to Unauthorized Website Availability

    Abbott is recalling ARCHITECT HBsAg assay files because they were mistakenly made available on its website and via AbbottLink notifications.

    Product
    ARCHITECT HBsAg Qualitative Assay, List Number 4P53 and ARCHITECT HBsAg Qualitative Confirmatory Assay, List Number 4P54 The ARCHITECT HBsAg Qualitative assay is a chemiluminescent microparticle immunoassay (CMIA) for the qualitative detection of hepatitis B surface antigen (H
    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.