Beckman Coulter Inc.
227 recalls on record · Latest: Feb 11, 2026
FDA Devices Moderate Jan 31, 2024
iQ200 Series Urine Microscopy Analyzers, Part Numbers: a) 700-3320, b) 700-3370, c) 700-3345, d) 700-3347, e) C10683, f) 700-3375, g) 7…
FDA Devices Moderate Jan 31, 2024
iQ Waste Well Adapter, Part Number: 700-3393
FDA Devices Moderate Oct 18, 2023
DxI 9000 Access Immunoassay Analyzer, REF C11137, Sofware Versions 1.15 and below; invitro diagnostic
FDA Devices Moderate Oct 18, 2023
Access Thyroglobulin Calibrators
FDA Devices Moderate Aug 2, 2023
Ringed DxI Reaction Vessels (RVs)
FDA Devices Moderate May 24, 2023
DxU 840m Iris Urine Microscopy Analyzer, Catalog Number C76947, in-vitro diagnostic device, urine analysis
FDA Devices Moderate May 24, 2023
iQ200 Series Urine Microscopy Analyzer: a) iQ 200 Select, Part Numbers C10684 and 700-3345; b) iQ 200 Elite, Part Numbers C10683 and 700-3375; in-v…
FDA Devices Moderate May 24, 2023
UA WIN 10 Kit, Catalog Number C52900, in-vitro diagnostic device, urine analysis
FDA Devices Moderate May 24, 2023
Beckman Coulter Bicarbonate, REF: OSR6137, 4x25 mL
FDA Devices Moderate May 24, 2023
Beckman Coulter Bicarbonate, REF: OS6637, 4x173 mL
FDA Devices Moderate Mar 22, 2023
Access Immunoassay Systems (1) Access 2 Immunoassay Analyzer (81600N); (2) Access 2 Immunoassay Analyzer, Refurbished (386220); (3) Access 2 Imm…
FDA Devices Moderate Jan 11, 2023
BECKMAN COULTER IRISpec CA/CB/CC control, REF 900-7211, For in vitro diagnostic use only.
FDA Devices Moderate Nov 30, 2022
MicroScan autoSCAN-4 Instrument, Catalog Number B1018-280
FDA Devices Moderate May 25, 2022
MicroScan WalkAway-40 plus Instrument REF B1018-283
FDA Devices Moderate May 25, 2022
DxM 1096 MicroScan WalkAway Instrument REF B1018-496
FDA Devices Moderate May 25, 2022
DxM 1040 MicroScan WalkAway Instrument REF B1018-440
FDA Devices Moderate Dec 29, 2021
SYNCHRON Systems Cholesterol (CHOL) Reagent, REF: 467825
FDA Devices Moderate Oct 13, 2021
Access hsTnI High Sensitivity Troponin I, REF B52699 Access Immunoassay System REAGENT PACK
FDA Devices Moderate Oct 6, 2021
DxA 5000 (DxA Automation System, DxA 5000 fit), "For in Vitro Diagnostic Use", Reference Numbers: B87352 with B57634, UDI: 15099590707118
FDA Devices Moderate Sep 1, 2021
Normand Remisol Advance Data Manager, REF: C69412, C69413, C44703, and C57017 is a software device that interfaces between laboratory information sys…
FDA Devices Moderate Aug 18, 2021
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 Only, UDI: (01)15099590742737;
FDA Devices Moderate Aug 18, 2021
ACCESS SARS-CoV-2 ANTIGEN EXTRACTION SOLUTION, CONTENTS: 6 x 6.0 mL EXTRACTION SOLN, IVD, Rx Only, UDI: (01)15099590743017
FDA Devices Moderate Aug 18, 2021
ACCESS SARS-CoV-2 Antigen , REF: C68668, IVD, Rx only, UDI: (01) 15099590742713;
FDA Devices Moderate Aug 18, 2021
Kaluza C Flow Cytometry Software Versions: 1.0*, 1.1.1 and 1.1.2 Kits: C10574 - Kaluza C Single Perpetual License C10575 - Kaluza C Single User 1…
FDA Devices Moderate Jun 30, 2021
Access SARS CoV-2 lgG II Reagent, REF: C69057, IVD CE UDI: (01)15099590742744
FDA Devices Moderate Jun 2, 2021
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, R1d, 3.10 mL, R1e
FDA Devices Moderate Apr 14, 2021
MicroScan WalkAway-40 plus Instrument
FDA Devices Moderate Apr 14, 2021
MicroScan WalkAway-40 plus Reconditioned Instrument
FDA Devices Moderate Apr 14, 2021
MicroScan WalkAway-96 plus Reconditioned Instrument
FDA Devices Moderate Apr 14, 2021
MicroScan WalkAway-96 plus Instrument
FDA Devices Moderate Dec 30, 2020
MicroScan Pos MIC Panel Type 34 - Product Usage: For the determination of antimicrobial agent susceptibility and/or identification to the species lev…
FDA Devices Moderate Oct 7, 2020
UIBC; Catalog Number: OSR61205; UDI (01) 15099590011925; IVD; Rx Only; WARNING H316 H317 H351 H373 H411 - Product Usage: System reagent for the quant…
FDA Devices Moderate Jun 10, 2020
Beckman Coulter ACCESS Immunoassay Systems, Access Total T3 Triiodothyronine , REF 33830 (UDI: 15099590227210) for use with the Access Family of Im…
FDA Devices Moderate Jun 10, 2020
Beckman Coulter ACCESS Immunoassay Systems, Access GI Monitor Cancer Antigen 19-9, REF 387687 ( UDI: 15099590231842) the Access Family of Immunoassa…
FDA Devices Moderate Jun 10, 2020
Beckman Coulter ACCESS Immunoassay Systems, Access Thyroglobulin, REF 33860 (UDI: 15099590227173) for use with the Access Family of Immunoassay Syste…
FDA Devices Moderate Jun 10, 2020
Beckman Coulter Access Immunoassay Systems, Access Free T3 Triiodothyronine, REF A13422 (UDI: 15099590201661) for use with the Access Family of Immu…
FDA Devices Moderate Jun 10, 2020
Beckman Coulter ACCESS Immunoassay Systems, Access Thyroglobulin Antibody II, REF A32898 (UDI: 15099590202910) for use with the Access Family of Im…
FDA Devices Moderate Jun 3, 2020
ISE Electrolyte Reference (2 X 2L) Reagent, REF A28937, UDI: 15099590202491 - Product Usage: are intended for the quantitative determination of carbo…
FDA Devices Moderate May 20, 2020
iChem¿VELOCITY Urine Chemistry System-
FDA Devices Moderate May 6, 2020
SYNCHRON Systems Barbiturates Reagent (BARB 1 X 250); Catalog No. 475012 - Product Usage: BARB reagent, in conjunction with UniCel DxC 600/800 System…
FDA Devices Moderate Apr 29, 2020
Synchron Systems Opiate 2000 ng Reagent (OP2 1 x 250); catalogue no. 475006 for use in conjunction with UniCel DxC 600/800 System(s) and SYNCHRON Sys…
FDA Devices Moderate Apr 15, 2020
LabPro Data Management System, UDI: 15099590676872 - Product Usage: The LabPro Data Management System is a Microsoft Windows based software program a…
FDA Devices Moderate Apr 15, 2020
Beckman Coulter MicroScan PROMPT Inoculation System-D, Catalog Number B1026-10D, UDI: 15099590659561 - Product Usage: The Prompt Inoculation System-D…
FDA Devices Moderate Apr 1, 2020
iChemVELOCITY Strips, Catalog 800-7212
FDA Devices Moderate Mar 11, 2020
Triglycerides Reagent (TG 2 x 300), REF: 445850, For In Vitro Diagnostic Use, Rx Only, UDI: 15099590233228
FDA Devices Moderate Mar 11, 2020
Enzymatic Creatinine Reagent (CR-E 2 X 200), REF A60298, For in Vitro Diagnostic Use, Rx Only, UDI: 15099590625733
FDA Devices Moderate Mar 11, 2020
Uric Acid Reagent (URIC 2 X 300), REF: 442785, For In Vitro Diagnostic Use, Rx Only, UDI: 15099590575281
FDA Devices Moderate Mar 11, 2020
Total Bilirubin Reagent (TBIL 2 x 300 ) and (TBIL 2 x 400), Ref:442745 (300 tests/cartridge) and 476861 (400 tests/cartridge), For In Vitro Diagnosti…
FDA Devices Moderate Feb 5, 2020
iChemVELOCITY, Urine Chemistry System, Catalog numbers: 700-7176-001, 700-7177-001, B75502 - Product Usage: used to automate the urine chemistry ana…
FDA Devices Moderate Feb 5, 2020