PlainRecalls

Abbott Laboratories, Inc

Compiled from official public sources by the publisher.

32 recalls on record · Latest: Mar 23, 2022

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Agency notice ledger

Federal filing book Abbott Laboratories, Inc MID-BOOK · SINGLE-AGENCY

#520 of 14,151 · 32 notices · 0.031% archive

  • BOOK 32 notices
  • RANK #520 of 14,151
  • SHARE 0.031% archive
  • AGENCY FDA Devices (32)
  • CAT medical devices
  • CATS 1 category
  • LATEST Mar 23, 2022
  • PHOTO American Medical Syst…

Nearest notice-volume peer: American Medical Systems Innovation Center - Silicon Valley (0 notice gap)

Abbott Laboratories, Inc accounts for about 0.031% of the 104,423-notice archive on 32 distinct filings — a mid share signal beside absolute volume. FDA · CPSC · USDA FSIS · NHTSA notice stamps for this firm. Read with this firm → · Dominant category → · Similar-volume firm →

Where Abbott Laboratories, Inc sits among 14,151 recalling firms

Abbott Laboratories, Inc ranks 520th of 14,151 tracked firms by distinct recall-event count. Archive size reflects filing volume, not inherent product danger.

Abbott Laboratories, Inc vs all firms by recall-notice count

Where this firm's archive sits among every tracked recalling manufacturer

32 520th of 14151 higher than 13,619 of 14,151 firms

Firms, banded by distinct federal recall-event inventory

Each bar is a band; taller bars hold more firms. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source FDA · CPSC · USDA FSIS · NHTSA federal recall filings · 2026-09-13

Abbott Laboratories, Inc in the notice-volume neighbourhood

Distinct federal recall events among this firm and nearest nationwide peers

notices

What this shows Abbott Laboratories, Inc holds about 0.031% of archive notices alongside 32 distinct filings.

Source FDA · CPSC · USDA FSIS · NHTSA filings aggregated by PlainRecalls As of September 2026
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 only. The Alinity s System is a highthroughput, fully automated immunoassay analyzer designed to determine the presence of specific antigens and antibodies by using chemiluminescent immunoassay technology.
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 screening, and organ donor centers, hospitals, and reference laboratories.
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 photometry and potentiometric technology. The mixer is a component and it is used on all ARCHITECT Clinical Chemistry systems to mix the sample with the reagent inside of the cuvettes.
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 antibody in the reagent, forming an immune complex. The immune complex causes an increase in light scattering, measured by reading turbidity at 604 nm, which correlates with the concentration of C4 in the sample.
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 sample bonds to the specific antibody in the reagent, forming an immune complex. The immune complex causes an increase in light scattering, measured by reading turbidity at 700 nm, which correlates with the concentration of immunoglobulin M in the sample.
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 apolipoprotein A1 combine with apolipoprotein A1 in the sample to form insoluble immune complexes. The immune complexes cause an increase in light scattering (turbidity). The resulting increase in sample turbidity, measured at 804 nm, is directly proportional to the concentration of apolipoprotein A1 in the sample.
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 sample bonds to the specific antibody in the reagent, forming an immune complex. The immune complex causes an increase in light scattering, measured by reading turbidity at 700 nm, which correlates with the concentration of immunoglobulin A in the sample.
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 sample bonds to the specific antibody in the reagent, forming an immune complex. The immune complex causes an increase in light scattering, measured by reading turbidity at 700 nm, which correlates with the concentration of immunoglobulin G in the sample.
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 apolipoprotein B combine with apolipoprotein B in the sample to form insoluble immune complexes. The immune complexes cause an increase in light scattering (turbidity). The resulting increase in sample turbidity, measured at 604 nm, is directly proportional to the concentration of apolipoprotein B in the sample.
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 bonds to the specific antibody in the reagent, forming an immune complex. The immune complex causes an increase in light scattering, measured by reading turbidity at 700 nm, which correlates with the concentration of transferrin in the sample.
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 to form insoluble immune complexes. The immune complexes cause an increase in light scattering (turbidity). The resulting increase in sample turbidity, measured at 604 nm, is directly proportional to the concentration of 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 kit was produced against purified human haptoglobin. The haptoglobin antibody interacts with the haptoglobin in the serum forming immune complexes . The immune complexes cause an increase in light scattering which correlates with the concentration of haptoglobin.
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 quantitation of sodium, potassium, and chloride in human serum, plasma, or urine.
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. The Abbott ARCHITECT Clinical Chemistry Systems are designed to perform automated chemistry tests, utilizing photometry and potentiometric technology. The ARCHITECT c4000, c8000, c16000 sample pipettor assemblies include a fluid sense/pressure monitoring system that helps identify errors in aspiration.
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. The Abbott ARCHITECT Clinical Chemistry Systems are designed to perform automated chemistry tests, utilizing photometry and potentiometric technology. The ARCHITECT c4000, c8000, c16000 sample pipettor assemblies include a fluid sense/pressure monitoring system that helps identify errors in aspiration.
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. The Abbott ARCHITECT Clinical Chemistry Systems are designed to perform automated chemistry tests, utilizing photometry and potentiometric technology. The ARCHITECT c4000, c8000, c16000 sample pipettor assemblies include a fluid sense/pressure monitoring system that helps identify errors in aspiration.
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 CM3000
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 cuvette segment holding 15 cuvettes for a total of 165 cuvettes per reaction carousel. The firm name on the label is Abbott Laboratories, Abbott Park, IL. The Abbott ARCHITECT Clinical Chemistry Systems are designed to perform automated chemistry tests utilizing photometry and potentiometric technology. The cuvette segments are a component of the sy
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 cuvette segment holding 11 cuvettes for a total of 99 cuvettes per reaction carousel. The firm name on the label is Abbott Laboratories, Abbott Park, IL. The Abbott ARCHITECT Clinical Chemistry Systems are designed to perform automated chemistry tests utilizing photometry and potentiometric technology. The cuvette segments are a component of the syst
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 cuvette segment holding 11 cuvette pairs (22 cuvettes) for a total of 165 cuvettes pairs or a total of 330 cuvettes (22 cuvettes x 15 cuvette segments) per reaction carousel. The firm name on the label is Abbott Laboratories, Abbott Park, IL. The Abbott ARCHITECT Clinical Chemistry Systems are designed to perform automated chemistry tests utilizi
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 a component to the ARCHITECT c4000 system. Cuvette segments are racks that sit in the reaction carousel and hold cuvettes. Each cuvette segment holds 11 cuvettes. With 9 segments, the reaction carousel holds 99 cuvettes. The Abbott ARCHITECT System is intended for In Vitro diagnostic use only. The system is designed to perform automated chemistry te
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 automated immunoassay tests, utilizing CMIA (chemiluminescent microparticle assay) detection technology.
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 Qualitative assay is a chemiluminescent microparticle immunoassay (CMIA) for the qualitative detection of hepatitis B surface antigen (HBsAg) in human adult and pediatric serum and plasma and neonate serum.

Abbott Laboratories, Inc holds a measurable archive slice

Drug and device firms outside this manufacturer and state, matched by notice volume and category footprint.

Frequently Asked Questions

How many federal recall notices name Abbott Laboratories, Inc? ▼
PlainRecalls indexes 32 distinct federal recall events naming Abbott Laboratories, Inc, aggregated from FDA, CPSC, USDA FSIS, and NHTSA filings (archive as of September 2026). That count is an issuance inventory, not a hazard score.
Where does Abbott Laboratories, Inc sit among other recalling firms? ▼
Abbott Laboratories, Inc ranks #520 of 14,151 by distinct recall-event count among 14,151 firms in this archive (96th percentile of firms with fewer notices). Rank tracks filing frequency, not product danger.
Which agency issues most of Abbott Laboratories, Inc's notices? ▼
FDA Devices accounts for 32 of this firm's 32 indexed notices.
What product category dominates Abbott Laboratories, Inc's filing book? ▼
Filings for Abbott Laboratories, Inc span 1 product category, led by medical devices. Browse that category archive for peer firms and related notices.
Is a higher notice count more dangerous? ▼
No. Archive size reflects how often federal agencies publish recalls naming the firm — reporting volume, coverage, and product range all move the number. Always verify the individual notice with the issuing agency before acting on a specific product.
Abbott Laboratories, Inc: 32 federal recall notices aggregated from FDA, CPSC, USDA FSIS, and NHTSA filings (lead agency FDA Devices). Verify individual notices with FDA directly before acting on a specific recall.

Firm-level totals aggregate distinct federal recall events naming Abbott Laboratories, Inc; individual notices remain authoritative on each linked recall page.

Methodology · Corrections · FDA · CPSC · USDA FSIS · NHTSA · Archive as of September 2026