Beckman Coulter Inc.
Brea, CA
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.
547
Total Recalls
2002
First Recall
2025
Most Recent
DxFLEX Flow Cytometer Catalog Number C78500
UDI-DI code: 15099590754013
The DxFLEX Flow Cytometer is intended...
Nov 18, 2025
· Device
Open, Classified
SYNCHRON Systems Direct LDL Cholesterol (LDLD) Reagent, REF: 969706
Nov 6, 2025
· Device
Open, Classified
SYNCHRON Systems Phosphorus (PHOSm) Reagent
REF: 467868
For In Vitro Diagnostic Use, Rx Only.
Oct 8, 2025
· Device
Open, Classified
DxC 500 AU Module w/ISE, DxC 500i, With ISE, REF: C63522 and DxC 500 AU Module, DxC 500i, Without ISE, REF: C6...
Oct 2, 2025
· Device
Open, Classified
UniCel DxH 600 COULTER Cellular Analysis System, configured with the Led HGB Photometer
REF:B23858
Sep 17, 2025
· Device
Open, Classified
UniCel DxH 900 COULTER Cellular Analysis System, configured with the Led HGB Photometer
REF: C11478
Sep 17, 2025
· Device
Open, Classified
UniCel DxH 800 COULTER Cellular Analysis System, configured with the Led HGB Photometer
REFs:B24802, 629029, B...
Sep 17, 2025
· Device
Open, Classified
UniCel DxH 690T COULTER Cellular Analysis System, configured with the Led HGB Photometer
REF: C34520
Sep 17, 2025
· Device
Open, Classified
UIBC (Unsaturated Iron Binding Capacity), REF: OSR61205,
Aug 4, 2025
· Device
Open, Classified
Estrone RIA, REF: DSL8700.
Estrone RIA is an IVD used for the quantitative measurement of estrone in human ser...
Jul 21, 2025
· Device
Open, Classified
REMISOL Advance
UDI-DI code: 13700962601874
All Software Versions:
B92487; B92488; C24317; C28652; C37500; D04...
Jun 25, 2025
· Device
Open, Classified
DxC 500 AU Clinical Chemistry Analyzer, Catalog Numbers/UDI codes:
C63519 / 14987666545058
C63520 / 1498766654...
May 15, 2025
· Device
Open, Classified
DxC 500 AU Clinical Chemistry Analyzer, Catalog Numbers/UDI codes:
C63519 / 14987666545058
C63520 / 1498766654...
Apr 25, 2025
· Device
Open, Classified
DxC 500 AU Clinical Chemistry Analyzer, Catalog Numbers/UDI codes:
C63519 / 14987666545058
C63520 / 1498766654...
Apr 3, 2025
· Device
Open, Classified
Access PCT Reagent Pack, Catalog Number C53987, when used on Access 2 and UniCel Dxl Immunoassay Systems
Feb 5, 2025
· Device
Open, Classified
Access Intact PTH assay on the DxI 9000 Access Immunoassay Analyzer, Catalog number A16972, for the quantitati...
Dec 11, 2024
· Device
Open, Classified
IMMAGE Immunochemistry Systems IGM Immunoglobulin M Reagent REF 447610
IGM reagent, when used in conjunction...
Oct 17, 2024
· Device
Open, Classified
Beckman Coulter, REF: OSR61173, IGM 4x14 mL R1, 4x11 mL R2
Jul 24, 2024
· Device
Open, Classified
Beckman Coulter, IVD, REF: OSR61171, IgA, 4 x 14 mL R1, 4 x 11 mL R2
Aug 31, 2023
· Device
Open, Classified
Beckman Coulter Bicarbonate, REF: OSR6137, 4x25 mL
May 18, 2023
· Device
Open, Classified
Beckman Coulter Bicarbonate, REF: OS6637, 4x173 mL
May 18, 2023
· Device
Open, Classified
Beckman Coulter Bicarbonate, REF: OSR6237, 4x50 mL
May 18, 2023
· Device
Open, Classified
AU/DxC AU Magnesium, Catalog/REF Number OSR6189, UDI 15099590010850
Dec 8, 2021
· Device
Terminated
SYNCHRON Systems Cholesterol (CHOL) Reagent, REF: 467825
Nov 10, 2021
· Device
Open, Classified
Power Processor 3K, 3K High Speed Stockyards
Module Nameplate:
PP 3K Stockyard (Refrig) 9707 REF A88116
Oct 14, 2021
· Device
Open, Classified
Access hsTnI High Sensitivity Troponin I, REF B52699
Access Immunoassay System REAGENT PACK
Aug 9, 2021
· Device
Open, Classified
Access SARS CoV-2 IgG (1st IS) Assay:
Access Immunoassay Systems REAGENT PACK, REF C74339
Access SARS-Co...
Aug 5, 2021
· Device
Terminated
DxA 5000 (DxA Automation System, DxA 5000 fit), "For in Vitro Diagnostic Use", Reference Numbers: B87352 with...
Jul 21, 2021
· Device
Terminated
Normand Remisol Advance Data Manager, REF: C69412, C69413, C44703, and C57017 is a software device that interf...
Jul 15, 2021
· Device
Terminated
ACCESS SARS-CoV-2 ANTIGEN QC, REF: C68670, CONTENTS: 3 X 6.0 mL QC1, 3 x 6.0 mL QC2, 1 QC VALUE CARD, IVD, Rx...
Jul 1, 2021
· Device
Terminated
Access SARS-CoV-2 Antigen Calibrators, Catalog, REF: C68669, Contents: 1x2.5 mL C0, 1x2.5mL C1, 1x CAL CARD,...
Jul 1, 2021
· Device
Terminated
ACCESS SARS-CoV-2 Antigen , REF: C68668, IVD, Rx only, UDI: (01) 15099590742713;
Jul 1, 2021
· Device
Terminated
ACCESS SARS-CoV-2 ANTIGEN EXTRACTION SOLUTION, CONTENTS: 6 x 6.0 mL EXTRACTION SOLN, IVD, Rx Only, UDI: (01)1...
Jul 1, 2021
· Device
Terminated
Access SARS CoV-2 lgG II Reagent, REF: C69057, IVD CE UDI: (01)15099590742744
May 7, 2021
· Device
Terminated
Access SARS-CoV-2 lgG II Calibrator, REF C69058, IVD, CE UDI: (01)15099590742751
May 7, 2021
· Device
Terminated
Access SARS-CoV-2 Antigen, REF C68668, UDI: (01)15099590742713, 3.30 mL/R1a, 4.70 mL/R1b, 4.20 mL/R1c, 3.10 mL...
Apr 14, 2021
· Device
Terminated
ACCESS SARS-CoV-2 IgG QC SARS-CoV-2 IgG REF C58964 - Product Usage: use on the Access Family of Immunoassay Sy...
Dec 30, 2020
· Device
Terminated
MicroScan Pos MIC Panel Type 34 - Product Usage: For the determination of antimicrobial agent susceptibility a...
Dec 2, 2020
· Device
Terminated
BECKMAN COULTER ACCESS Immunoassay Systems - Access Unconjugated Estriol, REF 33570.
Aug 26, 2020
· Device
Terminated
UIBC; Catalog Number: OSR61205; UDI (01) 15099590011925; IVD; Rx Only; WARNING H316 H317 H351 H373 H411 - Prod...
Aug 18, 2020
· Device
Terminated
Beckman Coulter ACCESS Immunoassay Systems, Access GI Monitor Cancer Antigen 19-9, REF 387687 ( UDI: 15099590...
Jun 2, 2020
· Device
Terminated
Beckman Coulter ACCESS Immunoassay Systems, Access Thyroglobulin, REF 33860 (UDI: 15099590227173) for use with...
Jun 2, 2020
· Device
Terminated
Beckman Coulter Access Immunoassay Systems, Access Free T3 Triiodothyronine, REF A13422 (UDI: 15099590201661)...
Jun 2, 2020
· Device
Terminated
Beckman Coulter ACCESS Immunoassay Systems, Access Total T3 Triiodothyronine , REF 33830 (UDI: 15099590227210...
Jun 2, 2020
· Device
Terminated
Beckman Coulter ACCESS Immunoassay Systems, Access Thyroglobulin Antibody II, REF A32898 (UDI: 15099590202910...
Jun 2, 2020
· Device
Terminated
Beckman Coulter Access Immunoassay Systems, Access Free T4 Thyroxine, REF 33880 (UDI:15099590225834) for use w...
Jun 2, 2020
· Device
Terminated
ISE Electrolyte Reference (2 X 2L) Reagent, REF A28937, UDI: 15099590202491 - Product Usage: are intended for...
May 28, 2020
· Device
Terminated
iQ200 Series Urine Microscopy Analyzer- All part numbers
May 9, 2020
· Device
Terminated
iChemVELOCITY Urine Chemistry System-
May 9, 2020
· Device
Terminated
Synchron Systems Opiate 2000 ng Reagent (OP2 1 x 250); catalogue no. 475006 for use in conjunction with UniCel...
Apr 20, 2020
· Device
Terminated