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Beckman Coulter Inc. Recalls

212 recalls on record. Search official CPSC, FDA, and USDA datasets for every recall issued for Beckman Coulter Inc..

212Total Recalls
6Critical
8.8MUnits Affected
Mar 16, 2026Most Recent
All Recalls

Every Beckman Coulter Inc. Recall

Sorted by most recent. Click any recall for full details.

212 recalls
High RiskFDA
Beckman Coulter, Inc.
DxI 9000 Access Immunoassay Analyzer, REF C11137, Sofware Versions 1.15 and below; invitro diagnostic
Diagnostic Devices·36 affected·Sep 12, 2023
High RiskFDA
Beckman Coulter, Inc.
Ringed DxI Reaction Vessels (RVs)
Medical Devices·213 affected·Jun 20, 2023
High RiskFDA
Beckman Coulter, Inc.
DxU 840m Iris Urine Microscopy Analyzer, Catalog Number C76947, in-vitro diagnostic device, urine analysis
Diagnostic Devices·355 affected·Apr 5, 2023
High RiskFDA
Beckman Coulter, Inc.
iQ200 Series Urine Microscopy Analyzer: a) iQ 200 Select, Part Numbers C10684 and 700-3345; b) iQ 200 Elite, Part Numbers C10683 and 700...
Diagnostic Devices·1,068 affected·Apr 5, 2023
High RiskFDA
Beckman Coulter, Inc.
UA WIN 10 Kit, Catalog Number C52900, in-vitro diagnostic device, urine analysis
Diagnostic Devices·306 affected·Apr 5, 2023
High RiskFDA
Beckman Coulter Inc.
Beckman Coulter Bicarbonate, REF: OSR6137, 4x25 mL
Medical Devices·48,633 affected·Apr 5, 2023
High RiskFDA
Beckman Coulter Inc.
Beckman Coulter Bicarbonate, REF: OS6637, 4x173 mL
Medical Devices·48,633 affected·Apr 5, 2023
High RiskFDA
Beckman Coulter, Inc.
MicroScan autoSCAN-4 Instrument, Catalog Number B1018-280
Medical Devices·53 affected·Oct 3, 2022
High RiskFDA
Beckman Coulter Inc.
SYNCHRON Systems Cholesterol (CHOL) Reagent, REF: 467825
Diagnostic Devices·1,433 affected·Nov 10, 2021
High RiskFDA
Beckman Coulter Inc.
Access hsTnI High Sensitivity Troponin I, REF B52699 Access Immunoassay System REAGENT PACK
Diagnostic Devices·293,640 affected·Aug 9, 2021
High RiskFDA
Beckman Coulter Inc.
DxA 5000 (DxA Automation System, DxA 5000 fit), "For in Vitro Diagnostic Use", Reference Numbers: B87352 with B57634, UDI: 15099590707118
Diagnostic Devices·123 affected·Jul 21, 2021
High RiskFDA
Beckman Coulter Inc.
Normand Remisol Advance Data Manager, REF: C69412, C69413, C44703, and C57017 is a software device that interfaces between laboratory inf...
Medical Devices·180 affected·Jul 15, 2021
High RiskFDA
Beckman Coulter Inc.
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;
Medical Devices·544 affected·Jul 1, 2021
High RiskFDA
Beckman Coulter Inc.
ACCESS SARS-CoV-2 ANTIGEN EXTRACTION SOLUTION, CONTENTS: 6 x 6.0 mL EXTRACTION SOLN, IVD, Rx Only, UDI: (01)15099590743017
Medical Devices·3,672 affected·Jul 1, 2021
High RiskFDA
Beckman Coulter Inc.
ACCESS SARS-CoV-2 Antigen , REF: C68668, IVD, Rx only, UDI: (01) 15099590742713;
Medical Devices·3,672 affected·Jul 1, 2021
High RiskFDA
Beckman Coulter, Inc.
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 S...
Medical Devices·1,085 affected·Jun 23, 2021
High RiskFDA
Beckman Coulter Inc.
Access SARS CoV-2 lgG II Reagent, REF: C69057, IVD CE UDI: (01)15099590742744
Diagnostic Devices·13,337 affected·May 7, 2021
High RiskFDA
Beckman Coulter Inc.
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
Medical Devices·1,034 affected·Apr 14, 2021
High RiskFDA
Beckman Coulter Inc.
MicroScan Pos MIC Panel Type 34 - Product Usage: For the determination of antimicrobial agent susceptibility and/or identification to the...
Medical Devices·685 affected·Dec 2, 2020
High RiskFDA
Beckman Coulter Inc.
UIBC; Catalog Number: OSR61205; UDI (01) 15099590011925; IVD; Rx Only; WARNING H316 H317 H351 H373 H411 - Product Usage: System reagent f...
Diagnostic Devices·219 affected·Aug 18, 2020
High RiskFDA
Beckman Coulter Inc.
iChem¿VELOCITY Urine Chemistry System-
Medical Devices·1,557 affected·Mar 30, 2020
High RiskFDA
Beckman Coulter, Inc.
iChemVELOCITY Strips, Catalog 800-7212
Medical Devices·10,822 affected·Feb 17, 2020
High RiskFDA
Beckman Coulter Inc.
ISE Electrolyte Reference (2 X 2L) Reagent, REF A28937, UDI: 15099590202491 - Product Usage: are intended for the quantitative determinat...
Diagnostic Devices·2,738 affected·Jan 29, 2020
High RiskFDA
Beckman Coulter Inc.
LabPro Data Management System, UDI: 15099590676872 - Product Usage: The LabPro Data Management System is a Microsoft Windows based softwa...
Medical Devices·177 affected·Jan 17, 2020
High RiskFDA
Beckman Coulter Inc.
Beckman Coulter MicroScan PROMPT Inoculation System-D, Catalog Number B1026-10D, UDI: 15099590659561 - Product Usage: The Prompt Inoculat...
Medical Devices·3,472 affected·Dec 13, 2019
High RiskFDA
Beckman Coulter Inc.
iChemVELOCITY, Urine Chemistry System, Catalog numbers: 700-7176-001, 700-7177-001, B75502 - Product Usage: used to automate the urine c...
Medical Devices·4,314 affected·Oct 28, 2019
High RiskFDA
Beckman Coulter Inc.
iQ200 Series Urine Microscopy Analyzer, Catalog numbers: 700-3345, 700-3375, 700-3325, 700-3347, 700-3300RFB, 700- 3320, 700-3320RFB, 70...
Medical Devices·6,601 affected·Oct 28, 2019
High RiskFDA
Beckman Coulter Inc.
MicroScan WalkAway-40 plus Instrument REF B1018-283
Medical Devices·22 affected·Oct 21, 2019
High RiskFDA
Beckman Coulter Inc.
DxM 1096 MicroScan WalkAway Instrument REF B1018-496
Medical Devices·49 affected·Oct 21, 2019
High RiskFDA
Beckman Coulter Inc.
DxM 1040 MicroScan WalkAway Instrument REF B1018-440
Medical Devices·40 affected·Oct 21, 2019
High RiskFDA
Beckman Coulter, Inc.
UniCel DxH Slidemaker Stainer (DxH SMS) and UniCel DxH Slidemaker Stainer II (DxH SMS II) - Product Usage: The intended use is as follows...
Medical Devices·1,056 affected·Oct 7, 2019
High RiskFDA
Beckman Coulter Inc.
MicroScan WalkAway-40 plus Instrument
Medical Devices·16 affected·Sep 4, 2019
High RiskFDA
Beckman Coulter Inc.
MicroScan WalkAway-40 plus Reconditioned Instrument
Medical Devices·6 affected·Sep 4, 2019
High RiskFDA
Beckman Coulter Inc.
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 ...
Diagnostic Devices·1,610 affected·Sep 4, 2019
High RiskFDA
Beckman Coulter Inc.
MicroScan WalkAway-96 plus Reconditioned Instrument
Medical Devices·9 affected·Sep 4, 2019
High RiskFDA
Beckman Coulter Inc
Triglycerides Reagent (TG 2 x 300), REF: 445850, For In Vitro Diagnostic Use, Rx Only, UDI: 15099590233228
Diagnostic Devices·0 affected·Aug 15, 2019
High RiskFDA
Beckman Coulter Inc
Enzymatic Creatinine Reagent (CR-E 2 X 200), REF A60298, For in Vitro Diagnostic Use, Rx Only, UDI: 15099590625733
Diagnostic Devices·2,581 affected·Aug 15, 2019
High RiskFDA
Beckman Coulter Inc
Uric Acid Reagent (URIC 2 X 300), REF: 442785, For In Vitro Diagnostic Use, Rx Only, UDI: 15099590575281
Diagnostic Devices·16,983 affected·Aug 15, 2019
High RiskFDA
Beckman Coulter Inc
Total Bilirubin Reagent (TBIL 2 x 300 ) and (TBIL 2 x 400), Ref:442745 (300 tests/cartridge) and 476861 (400 tests/cartridge), For In Vit...
Diagnostic Devices·25,383 affected·Aug 15, 2019
High RiskFDA
Beckman Coulter Inc.
SYNCHRON Systems Barbiturates Reagent (BARB 1 X 250); Catalog No. 475012 - Product Usage: BARB reagent, in conjunction with UniCel DxC 60...
Diagnostic Devices·10,145 affected·Jun 12, 2019
High RiskFDA
Beckman Coulter Inc.
Beckman Coulter ACCESS Immunoassay Systems, Access Total T3 Triiodothyronine , REF 33830 (UDI: 15099590227210) for use with the Access ...
Diagnostic Devices·238,862 affected·Apr 30, 2019
High RiskFDA
Beckman Coulter Inc.
Beckman Coulter ACCESS Immunoassay Systems, Access GI Monitor Cancer Antigen 19-9, REF 387687 ( UDI: 15099590231842) the Access Family o...
Diagnostic Devices·150,887 affected·Apr 30, 2019
High RiskFDA
Beckman Coulter Inc.
Beckman Coulter ACCESS Immunoassay Systems, Access Thyroglobulin, REF 33860 (UDI: 15099590227173) for use with the Access Family of Immun...
Diagnostic Devices·95,453 affected·Apr 30, 2019
High RiskFDA
Beckman Coulter Inc.
Beckman Coulter Access Immunoassay Systems, Access Free T3 Triiodothyronine, REF A13422 (UDI: 15099590201661) for use with the Access Fa...
Diagnostic Devices·418,400 affected·Apr 30, 2019
High RiskFDA
Beckman Coulter Inc.
Beckman Coulter ACCESS Immunoassay Systems, Access Thyroglobulin Antibody II, REF A32898 (UDI: 15099590202910) for use with the Access ...
Diagnostic Devices·123,324 affected·Apr 30, 2019
High RiskFDA
Beckman Coulter Inc.
UniCel DxC 660i, 680i, 860i, and 880i SYNCHRON Access Clinical Systems, that are re-configured so that the DxI system is separated from t...
Medical Devices·0 affected·Dec 5, 2018
High RiskFDA
Beckman Coulter Inc.
iChem VELOCITY Urine Chemistry Strips, REF 800-7212, 100 test strips/vial. The firm name on the label is Beckman Coulter Ireland, Inc., ...
Medical Devices·956,798 affected·Oct 18, 2018
High RiskFDA
Beckman Coulter Inc.
The Access Cortisol Reagent. REF (Catalog Number) 33600, Lot 831755. A paramagnetic particle, chemiluminscent immunoassay. Product Usage...
Diagnostic Devices·0 affected·Sep 18, 2018