Abbott Laboratories
Irving, TX
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.
18
Total Recalls
2019
First Recall
2025
Most Recent
Alinity ci-series System Control Module (SCM), REF: 03R70-01, 03R70-20
Dec 18, 2025
· Device
Open, Classified
Alinity i Processing Module REF 03R65-01
The Alinity i Processing Module is a fully automated immunoassay an...
Jan 9, 2024
· Device
Open, Classified
Alinity c Processing Module REF 03R67-01
The Alinity c Processing Module is a fully automated chemistry anal...
Jan 9, 2024
· Device
Open, Classified
ARCHITECT c4000 Processing Module REF:
02P24-01
02P24-02
02P24-40
01R24-56
01R25-56
The Abbott ARCHITECT c40...
Jan 9, 2024
· Device
Open, Classified
Alinity ci-series System Control Module, REF: 03R70-01
Dec 22, 2023
· Device
Open, Classified
Alinity Reaction Vessels, REF: 06P1401, for use with Alinity i Systems; ARCHITECT Reaction Vessels
Jan 17, 2023
· Device
Open, Classified
REF: 08P4377, Alinity c Hemoglobin Reagent Kit, IVD, CE, R1 5 x 46.0 mL, R2 5 x 18.3 mL, A1cDL 5 x 67.6 mL
Jun 9, 2022
· Device
Open, Classified
REF: 4P52-20 Hemoglobin A1c for use with Architect, IVD, CE, R1 1 x 52 mL, R2 1 x 20 mL, A1cDL 2 x 35 mL
Jun 9, 2022
· Device
Open, Classified
REF: 08P4320, Alinity c Hemoglobin Reagent Kit, IVD, CE, R1 5 x 46.0 mL, R2 5 x 18.3 mL, A1cDL 5 x 67.6 mL
Jun 9, 2022
· Device
Open, Classified
ARCHITECT c4000 REF 02P24-01/2P24, 1P86, 1R24, and 1R25;
ARCHITECT c8000 REF 01G06-11/1G06;
ARCHITECT c16000 R...
Sep 29, 2021
· Device
Open, Classified
ARCHITECT i1000SR REF 01L86-01/1L86 and 1L87;
ARCHITECT i2000SR REF 03M74-02/3M74;
ARCHITECT i2000 REF 08C89-0...
Sep 29, 2021
· Device
Open, Classified
Alinity ci-series System Control Module clinical chemistry and immunoassay analyzer for in vitro diagnostic us...
Jul 26, 2021
· Device
Open, Classified
REF 8L92-21, Abbott Activated Alanine Aminotransferase, for use with Architect, IVD, CE, UDI: (01) 00380740017...
Jun 10, 2021
· Device
Open, Classified
REF: 08P1820, Abbott Alinity c Activated Alanine Aminotransferase reagent Kit, Alinity c Activated Alanine Am...
Jun 10, 2021
· Device
Open, Classified
REF 8L92-42, Abbott Activated Alanine Aminotransferase, for use with Architect, IVD, CE, UDI: (01) 00380740161...
Jun 10, 2021
· Device
Open, Classified
REF 8L92-22, Abbott Activated Alanine aminotransferase, for use with Architect, IVD, CE, UDI: (01) 00380740161...
Jun 10, 2021
· Device
Open, Classified
Accelerator APS Aliquoter Module, List number: 07L40 - Product Usage: The ACCELERATOR APS Workcell is a modula...
Jun 3, 2020
· Device
Terminated
"HEMOGLOBIN A1c CALIBRATORS *** REF 4P52-01 *** 307261/R03 *** S4P5X0 *** FOR USE WITH ARCHITECT" - Product Us...
May 22, 2019
· Device
Terminated