PlainRecalls

Abbott Laboratories, Inc

Compiled from official public sources by the editorial team.

32 recalls on record · Latest: Mar 23, 2022

Abbott Laboratories, Inc Recall Insight

Abbott Laboratories, Inc appears on 32 federal recall records indexed by PlainRecalls, out of 101,704 total recalls tracked across the FDA, CPSC, and NHTSA. That represents approximately 0.031% of the federal archive, a data point that is only interpretable alongside production volume, product mix, and decades of operation, because a high recall count alone does not establish fault. Large, diversified firms that sell tens of millions of units across many categories will mechanically accumulate more recall records than small manufacturers, even when their defect rates per unit shipped are comparable or lower. The most recent action on this firm is dated Mar 23, 2022, which is the anchor point for assessing whether enforcement is currently active or historical.

On this page of 32 entries, severity tagging shows 0 critical, 32 moderate, and 0 lower-severity recalls. Affected-unit counts are disclosed on 32 of 32 entries, unit-count disclosure is more common on CPSC and NHTSA actions and less common on FDA drug/device recalls, where lot numbers and distribution scope substitute for absolute totals. The records on this page span 1 distinct product categories, with issuing agencies dominated by FDA Devices (32). The date window on this page runs from Apr 3, 2013 to Mar 23, 2022.

Manufacturer-level browsing is useful when monitoring a single firm for patterns, whether recalls cluster around one product family (suggesting a specific design or supplier issue) or scatter across the firm's entire catalog (which can indicate systemic quality-control problems or deliberate regulator attention). Clicking into each recall reveals the specific hazard, remedy, and distribution scope that together determine whether a consumer is actually at risk. For decisions that depend on being current, deciding whether a product in your home is safe, whether to return a gift, or whether to accept a replacement, always verify the recall number on the issuing agency's site, because federal agencies amend, terminate, and re-scope recalls over time and only the agency's live record reflects the current legal status. This page aggregates what agencies have published publicly and is intended for consumer awareness and research.

FDA Devices Moderate Mar 23, 2022

Alinity s System software version2.8.0, REF LN 06P16-01, IVD, OEI: (01)00380740138479 The Alinity s System is intended for In Vitro diagnostic use…

FDA Devices Moderate Aug 18, 2021

Alinity s System REF 06P16-01. An automated immunoassay analyzer for In Vitro diagnostic use in blood donor screening, plasma and plasmapheresis sc…

FDA Devices Moderate Apr 15, 2020

ARCHITECT C System Mixer - Product Usage: The ARCHITECT Clinical Chemistry System is designed to perform automated chemistry tests, utilizing photome…

FDA Devices Moderate Oct 2, 2019

APS Accelerator modular systems, 208-230 V-, 50/60 Hz, 1800 VA, IVD, RX, Class 2 Laser Product,

FDA Devices Moderate Jul 31, 2019

C4 is an in vitro diagnostic assay for the quantitative determination of C4 in human serum or plasma. Antigen in the sample bonds to the specific an…

FDA Devices Moderate Jul 31, 2019

Immunoglobulin M is an in vitro diagnostic assay for the quantitative determination of immunoglobulin M in human serum or plasma. Antigen in the sam…

FDA Devices Moderate Jul 31, 2019

Apolipoprotein A1 is an in vitro diagnostic assay for the quantitative determination of apolipoprotein A1 in human serum or plasma. Antibodies to ap…

FDA Devices Moderate Jul 31, 2019

Immunoglobulin A is an in vitro diagnostic assay for the quantitative determination of immunoglobulin A in human serum or plasma. Antigen in the sam…

FDA Devices Moderate Jul 31, 2019

Immunoglobulin G is an in vitro diagnostic assay for the quantitative determination of immunoglobulin G in human serum or plasma. Antigen in the sam…

FDA Devices Moderate Jul 31, 2019

Apolipoprotein B is an in vitro diagnostic assay for the quantitative determination of apolipoprotein B in human serum or plasma. Antibodies to apol…

FDA Devices Moderate Jul 31, 2019

Transferrin is an in vitro diagnostic assay for the quantitative determination of transferrin in human serum or plasma. Antigen in the sample bond…

FDA Devices Moderate Jul 31, 2019

C3 is an in vitro diagnostic assay for the quantitative determination of C3 in human serum or plasma. Antibodies to C3 combine with C3 in the sample…

FDA Devices Moderate Jul 31, 2019

The,K -ASSAY HP assay is intended for the quantitative determination of human haptoglobin by immunoturbidimetric assay. The antiserum used in the k…

FDA Devices Moderate May 15, 2019

Abbott ARCHITECT cSystems ICT Module, REF 09D28-03. Product Usage: The ARCHITECT cSystems ICT (Integrated Chip Technology) is used for the quanti…

FDA Devices Moderate Apr 17, 2019

Abbott ARCHITECT c4000 Processing Module, List No. 02P24 - Product Usage: The Abbott ARCHITECT System is intended for In Vitro diagnostic use only. T…

FDA Devices Moderate Apr 17, 2019

Abbott ARCHITECT c16000 Processing Module, List No. 03L77 - Product Usage: The Abbott ARCHITECT System is intended for In Vitro diagnostic use only. …

FDA Devices Moderate Apr 17, 2019

Abbott ARCHITECT c8000 Processing Module, List No. 01G06 - Product Usage: The Abbott ARCHITECT System is intended for In Vitro diagnostic use only. T…

FDA Devices Moderate Apr 10, 2019

Abbott ARCHITECT Creatine Kinase, IVD, REF 7D6341.

FDA Devices Moderate Apr 10, 2019

Abbott ARCHITECT Creatine Kinase, IVD, REF 7D63-21.

FDA Devices Moderate Mar 13, 2019

ARCHITECT MAGNESIUM, (a) REF 7D70-21, (b) 7D70-31 The Magnesium assay is used for the quantitation of magnesium in human serum, plasma, or urine.

FDA Devices Moderate Aug 1, 2018

CardioMEMS HF System Hospital and Patient Electronics Units: (a) Patient Electronics System, Model CM1100 (b) Hospital Electronics System, Model CM…

FDA Devices Moderate Mar 14, 2018

ARCHITECT c8000 Cuvette Segment, Part #01G46-01/01G06, a component to the ARCHITECT Clinical Chemistry system. There are 11 segments with each cuvet…

FDA Devices Moderate Mar 14, 2018

ARCHITECT c4000 Cuvette Segment, Part #02P75-01/02P24, a component to the ARCHITECT Clinical Chemistry system. There are 9 segments with each cuvett…

FDA Devices Moderate Mar 14, 2018

ARCHITECT c16000 Cuvette Segment, Part #09D32-05/ 03L77, a component to the ARCHITECT Clinical Chemistry system. There are 15 segments with each cuv…

FDA Devices Moderate Nov 29, 2017

ARCHITECT c4000 part number 02P24; ARCHITECT c8000 part number 01G06; ARCHITECT c16000 part number 03L77 Clinical Chemistry systems.

FDA Devices Moderate Nov 29, 2017

Tubing, Peristaltic Head Part Number 7-35009685-01 for use in clinical chemistry systems.

FDA Devices Moderate Oct 18, 2017

ARCHITECT c4000 Cuvette Segment, List number 02P75-01. The firm name on the label is Abbott Laboratories, Abbott Park, IL. Cuvette segments are …

FDA Devices Moderate Nov 4, 2015

ARCHITECT i2000SR System The Abbott ARCHITECT System is intended for In Vitro diagnostic use only. The ARCHITECT system is designed to perform auto…

FDA Devices Moderate Nov 5, 2014

Lipase Reagent, 7D80. Used to measure lipase in human serum on the Architect system.

FDA Devices Moderate Oct 23, 2013

Clinical Chemistry Phosphorus Reagent The Phosphorus assay is used for the quantitation of phosphorus in human serum, plasma, or urine.

FDA Devices Moderate Apr 24, 2013

Clinical Chemistry Phenobarbital, list number 1E08

FDA Devices Moderate Apr 3, 2013

ARCHITECT HBsAg Qualitative Assay, List Number 4P53 and ARCHITECT HBsAg Qualitative Confirmatory Assay, List Number 4P54 The ARCHITECT HBsAg Quali…

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Data Sources

  • Source: FDA + CPSC + NHTSA - federal recall filings naming this firm. Verify with FDA, CPSC, or NHTSA directly.
  • Source: PlainRecalls Manufacturer Index - firm-level aggregation across all three federal recall feeds

Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. Recalls are aggregated across FDA, CPSC and NHTSA filings that name this firm; the total reflects the federal record, not an independent investigation. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.