Abbott Laboratories
Abbott Park, IL, United States
This page shows every FDA and USDA recall linked to Abbott Laboratories. Each entry includes the product involved, when the recall happened, and how serious it was. If a company has had multiple recalls over the years, you can see the full history here in one place — including whether any were Class I, which is the most serious type.
85
Total Recalls
2007
First Recall
2025
Most Recent
1
Class I (Most Serious)
Drug: 3
Food: 2
Device: 80
Class II: 4
Brand Name: CELL-DYN Ruby
Product Name: CELL-DYN Ruby
Model/Catalog Number: 08H67-01
Software Version: All sof...
Apr 22, 2025
· Device
Open, Classified
Brand Name: CELL-DYN Ruby
Product Name: CELL-DYN Ruby
Model/Catalog Number: 08H67-10
Software Version: All sof...
Apr 22, 2025
· Device
Open, Classified
Brand Name: CELL-DYN Ruby
Product Name: CELL-DYN Ruby
Model/Catalog Number: 08H67-13
Software Version: All sof...
Apr 22, 2025
· Device
Open, Classified
Brand Name: CELL-DYN Ruby
Product Name: CELL-DYN Ruby
Model/Catalog Number: 04U42-84
Software Version: All sof...
Apr 22, 2025
· Device
Open, Classified
Brand Name: CELL-DYN Ruby
Product Name: CELL-DYN Ruby
Model/Catalog Number: 08H67-03
Software Version: All sof...
Apr 22, 2025
· Device
Open, Classified
ARCHITECT STAT Myoglobin Reagent Kit, LN 2K43-25 and 2K43-20.
Apr 4, 2024
· Device
Open, Classified
Abbott CELL-DYN Ruby, Model CD-Ruby, List number 08H67-01, and Abbott CELL-DYN Sapphire, Model CD Sapphire, li...
Dec 21, 2023
· Device
Open, Classified
ARCHITECT STAT Troponin-I Reagent Kit, REF 2K41-27
Jul 26, 2022
· Device
Open, Classified
Abbott Similac Sensitive Infant Formula with Iron 22.5oz. plastic jar. 6 jars per case. Item numbers: 508...
Mar 16, 2022
· Food
Class I
Ongoing
ARCHITECT STAT Myoglobin Calibrators, RES 2K43-01
The ARCHITECT STAT Myoglobin Calibrators are for the calibr...
Mar 8, 2022
· Device
Open, Classified
ARCHITECT C Peptide Calibrator - Product Usage: used as an aid in the diagnosis and treatment of patients with...
Apr 1, 2020
· Device
Terminated
ARCHITECT C Peptide Calibrator - Product Usage: used as an aid in the diagnosis and treatment of patients with...
Apr 1, 2020
· Device
Terminated
ARCHITECT C Peptide Reagent - Product Usage: used as an aid in the diagnosis and treatment of patients with ab...
Apr 1, 2020
· Device
Terminated
Abbott Calcilo XD, Low-calcium Vitamin D-Free Infant formula with iron, powder in a 13.2 oz. can, with 6 cans...
Oct 16, 2019
· Food
Class II
Terminated
ARCHITECT BNP Calibrators
Ptoduct Usage:
The ARCHITECT BNP Calibrators are for the calibration of the ARCHITE...
May 24, 2019
· Device
Terminated
ARCHITECT BNP Controls
Ptoduct Usage:
The ARCHITECT BNP Controls are for the estimation of test precision an...
May 24, 2019
· Device
Terminated
ALINITY i Anti-TPO Calibrators - Product Usage: The Alinity i Anti-TPO Calibrators are for the calibration of...
Apr 9, 2019
· Device
Terminated
ARCHITECT Intact PTH Controls - Product Usage: The ARCHITECT Intact PTH Calibrators are for the calibration of...
Apr 9, 2019
· Device
Terminated
ARCHITECT Intact PTH Calibrators - Product Usage: The ARCHITECT Intact PTH Calibrators are for the calibration...
Apr 9, 2019
· Device
Terminated
Technopath Multichem S Plus Level 1 - Product Usage: Multichem S Plus (Assayed) is intended for use as an assa...
Apr 9, 2019
· Device
Terminated
Technopath Multichem S Plus Level 2 - Product Usage: Multichem S Plus (Assayed) is intended for use as an assa...
Apr 9, 2019
· Device
Terminated
ARCHITECT STAT High Sensitive Troponin-I Calibrators - Product Usage: The ARCHITECT STAT High Sensitive Tropo...
Apr 9, 2019
· Device
Terminated
ARCHITECT Sirolimus Calibrators - Product Usage: The ARCHITECT Sirolimus Calibrators are for the calibration o...
Apr 9, 2019
· Device
Terminated
ARCHITECT HbA1C Calibrators - Product Usage: The ARCHITECT HbA1c Calibrators are for the calibration of the AR...
Apr 9, 2019
· Device
Terminated
ARCHITECT STAT High Sensitive Troponin-I Controls - Product Usage: The ARCHITECT STAT High Sensitive Troponin-...
Apr 9, 2019
· Device
Terminated
ARCHITECT SHBG Reagent
The ARCHITECT SHBG assay is a chemiluminescent microparticle immunoassay (CMIA) for th...
May 3, 2017
· Device
Terminated
ARCHITECT Lactic Acid Part # 09D891T21
The Lactic Acid assay is used for the quantitation of lactic acid in h...
Nov 9, 2016
· Device
Terminated
The ARCHITECT Estradiol Kit
Intended to measure estradiol, an estrogenic steroid, in plasma.
Mar 24, 2016
· Device
Terminated
ARCHITECT c8000 System List Number 01G06-98
Product Usage: The Abbott ARCHITECT cSystem is intended for In V...
Jul 22, 2015
· Device
Terminated
ICT Serum Calibrator REF 146-03.
For use in the calibration of the serum Sodium, Potassium, and Chloride ass...
Jun 27, 2015
· Device
Terminated
Alkaline Wash, List number 9D31-20, a cleaning solution used by the Abbott Architect analyzers. It is supplied...
Jun 8, 2015
· Device
Terminated
HbA1c Calibrators LN 4P52-02 consists of: 4P52-02 Hemoglobin A1c 1 x 1.6 mL and 1 x 1.6 mL. A1c Calibrators (l...
Oct 24, 2014
· Device
Terminated
ARCHITECT Intact PTH Calibrators consists of 6 bottles (4.0 mL each). Calibrator A contains Bis Tris Propane b...
May 29, 2014
· Device
Terminated
ARCHITECT Intact PTH Controls consists of 3 x 1 Bottle (8.0 mL each) of PTH (synthetic peptide) in Bis Tris Pr...
May 29, 2014
· Device
Terminated
Abbott Laboratories, ARCHITECT 25-OH Vitamin D Reagent Kit, 03L52-25 (ROW) and 03L52-27 (U.S.) (1 x 100 tests)...
Jan 23, 2013
· Device
Terminated
Synthroid (Levothyroxine Sodium) tablets, 150 mcg (0.15 mg), 90 tablets per bottle, Rx Only, NDC 0074-7069-90;...
Jan 9, 2013
· Drug
Class II
Terminated
Synthroid (levothyroxine sodium) Tablets USP, 75 mcg, Rx Only, 90-Count Bottle, Abbott Laboratories, North Chi...
Oct 3, 2012
· Drug
Class II
Terminated
ARCHITECT CA 19-9XR Reagent Kit; ARCHITECT CA 19-9 Reagent Kit, list 291-20 (4 x 100 tests), 2K91-25 and 2K91-...
Jun 29, 2012
· Device
Terminated
Zemplar (paricalcitol) Injection, 5 mcg/mL in 2 mL multi-dose vials, 25 vial carton, Rx only, Manufactured by...
Jun 27, 2012
· Drug
Class II
Terminated
ARCHITECT STAT Troponin-I Reagent Kit; list numbers 2K41-28 (500 test kit); an in-vitro diagnostic test kit; e...
May 10, 2012
· Device
Terminated
ARCHITECT Cyclosporine; an in-vitro diagnostic chemiluminescent microparticle immunoassay (CMIA) for the quant...
Nov 4, 2011
· Device
Terminated
ARCHITECT C-Peptide Reagent Kit; a chemiluminescent microparticle immunoassay (CMIA) for the quantitative det...
Jul 11, 2011
· Device
Terminated
ARCHITECT HAVAB-M Assay Reagent; a chemiluminescent microparticle immunoassay (CMIA) for the qualitative detec...
Jun 6, 2011
· Device
Terminated
ARCHITECT iVancomycin Reagent; an in vitro chemiluminescent microparticle immunoassay (CMIA) for the quantitat...
Dec 16, 2010
· Device
Terminated
Architect Tacrolimus Reagent Kit; an in-vitro diagnostic chemiluminescent microparticle immunoassay (CMIA) for...
Oct 15, 2010
· Device
Terminated
Architect Sirolimus Reagent Pack; 100 test pack containing 1 bottle (8.0 mL) Anti-Sirolimus Coated Micropartic...
Aug 3, 2010
· Device
Terminated
IMx Sirolimus Reagent Pack; 100 test pack containing 1 bottle (9.7 mL) Anti-Sirolimus Antibody Coated Micropar...
Aug 3, 2010
· Device
Terminated
ARCHITECT i System Assay CD ROM - US, list 6E58-22, Version 22.01, and ARCHITECT i System Assay CD-ROM - WW (e...
Sep 30, 2009
· Device
Terminated
AxSYM System Tubing Decontamination Solution; 500 mL bottle; Abbott Laboratories, Diagnostics Division, Abbott...
Sep 30, 2009
· Device
Terminated
Abbott AxSYM Cancer Assay Disk Version 5.0, for in vitro diagnostic use with the AxSYM System; Abbott Laborato...
Sep 18, 2009
· Device
Terminated