Beckman Coulter, Inc.
Chaska, MN
This page shows every FDA and USDA recall linked to Beckman Coulter, Inc.. 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.
51
Total Recalls
2023
First Recall
2026
Most Recent
Beckman Coulter UniCel Dxl 800, Part numbers: 973100, A71456, A71457, A25288; Immunoassay Method, Troponin S...
Jan 6, 2026
· Device
Active
Beckman Coulter UniCel Dxl 600, Part numbers: A71460, A71461, A30260; Immunoassay Method, Troponin Subunit
Jan 6, 2026
· Device
Active
Access 2 Reaction Vessels, individual, disposable, plastic tubes used to process patient, quality control and...
Dec 9, 2025
· Device
Active
Beckman Coulter UniCel DxI 800, Part Numbers: 973100, A71456; Photometric Chemistry Analyzer
Nov 4, 2025
· Device
Active
Beckman Coulter UniCel DxI 600, Part Numbers: A71460, A30260; Photometric Chemistry Analyzer
Nov 4, 2025
· Device
Active
DxC 500i Clinical Analyzer Modules, DxC 500 AU Module w/ISE, DxC 500i (Part Number C63522), DxC 500 AU Module,...
Oct 21, 2025
· Device
Active
DxI 9000 Access Immunoassay Analyzer, Part Number C11137
Oct 21, 2025
· Device
Active
Access Thyroglobulin assay, a simultaneous one-step immunoenzymatic assay, Catalog Number 33860
Aug 13, 2025
· Device
Active
DxI 800 Access Immunoassay Analyzer W/Dual Gantry, Part Number A71457
Aug 5, 2025
· Device
Active
DxI 600 Access Immunoassay Analyzer W/Spot B, Part Number A71460
Aug 5, 2025
· Device
Active
DxI 600 Access Immunoassay Analyzer W/Dual Gantry, Part Number A71461
Aug 5, 2025
· Device
Active
UniCel DxI 800 Access Immunoassay Analyzer, Part Number 973100
Aug 5, 2025
· Device
Active
DxI 800 Access Immunoassay Analyzer W/Spot B, Part Number A71456
Aug 5, 2025
· Device
Active
UniCel DxI 600 Access Immunoassay Analyzer, Part Number A30260
Aug 5, 2025
· Device
Active
Access Vitamin B12 Reagent, Catalog Number 33000, Lot Number 439850
Jul 11, 2025
· Device
Active
DxI 9000 Access Immunoassay Analyzer C11137
Jun 20, 2025
· Device
Active
DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, running software versions 1.20
Jun 6, 2025
· Device
Active
DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, running software version 1.20
Jun 5, 2025
· Device
Active
Access Testosterone assay, Catalog Number 33560
Jun 2, 2025
· Device
Active
Beckman Coulter DxI 9000 Access Immunoassay Analyzer
Apr 24, 2025
· Device
Active
DxI 9000 Access Immunoassay Analyzer, catalog number C11137
in vitro diagnostic
device used for the quantitat...
Apr 4, 2025
· Device
Active
DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137.
Mar 17, 2025
· Device
Active
DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, with Component PCB, TSI/RSI firmware C29278
Mar 17, 2025
· Device
Active
Access 2 Immunoassay Analyzer, Catalog Number 81600N
Mar 17, 2025
· Device
Active
DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137
Mar 12, 2025
· Device
Active
Access Erythropoietin (EPO), Catalog Number - A16364
a glycoprotein (~30,400 Daltons) produced primarily by th...
Feb 28, 2025
· Device
Active
Beckman Coulter DxI 9000 Access Immunoassay Analyzer, catalog number C11137; in-vitro diagnostic instrument
Feb 6, 2025
· Device
Completed
Access hsTnI Reagent, REF B52699, Immunoassay Method, Troponin Subunit.
For the quantitative determination of...
Dec 20, 2024
· Device
Active
Access Thyroglobulin Antibody II, REF A32898, containing Instructions for Use, IFU REF B14994, B63978, and A38...
Oct 30, 2024
· Device
Active
The Access TSH (3rd IS) assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative et...
Oct 16, 2024
· Device
Active
Beckman Coulter Dxl 9000 Access Immunoassay Analyzer, REF #C11137. An in vitro diagnostic device used for the...
Oct 7, 2024
· Device
Active
Beckman Coulter DxI 9000 Access Immunoassay Analyzer, Model Number C21510, RSM Pneumatic Tubing Kit item #2, R...
Sep 19, 2024
· Device
Active
DxI 9000 Access Immunoassay Analyzer, REF C11137, vitro diagnostic device used for the quantitative, semi-quan...
Aug 30, 2024
· Device
Active
DxI 9000 Access Immunoassay Analyzer, Catalog #C11137.
Aug 27, 2024
· Device
Active
Discrete photometric chemistry analyzer for clinical use.
Aug 9, 2024
· Device
Active
Beckman Coulter DxI 9000 Access Immunoassay Analyzer, Catalog #C11137.
Aug 9, 2024
· Device
Active
Dxl 9000 Access Immunoassay Analyzer, Catalog #C11137.
Jul 23, 2024
· Device
Active
DxI 9000 Access Immunoassay Analyzer, C11137; in-vitro diagnostic
Jul 3, 2024
· Device
Active
Beckman Coulter DxI 9000 Access Immunoassay Analyzer is a discrete photometric chemistry analyzer for clinical...
Jun 28, 2024
· Device
Active
Access Substrate, REF 81906, For use with the Access Immunoassay Systems
Mar 25, 2024
· Device
Active
Access Total T4, REF 33800, IVD, thyroxine reagent assay.
Mar 15, 2024
· Device
Active
DxI 9000 Access Immunoassay Analyzer running software version 1.16 or prior,
Feb 5, 2024
· Device
Active
Access Ultrasensitive Insulin only used on the DxI 9000 Access Immunoassay Analyzer, Catalog Number 33410
Feb 5, 2024
· Device
Active
DxI 9000 Access Immunoassay Analyzer, REF C11137, Sofware Versions 1.15 and below; invitro diagnostic
Oct 12, 2023
· Device
Active
Access Thyroglobulin Calibrators
Oct 11, 2023
· Device
Active
Ringed DxI Reaction Vessels (RVs)
Jul 26, 2023
· Device
Active
Access Hybritech p2PSA reagent, REF B03704 and REF A49752.
Jun 30, 2023
· Device
Active
Beckman Coulter Access Free T3, Triiodothyronine, Free, Catalog #A13422, each box contains 2 reagent packs.
Apr 20, 2023
· Device
Active