Beckman Coulter recalls
Beckman Coulter appears in 334 official U.S. recall notices indexed by RecallRadar.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
- DxM 1096 MicroScan WalkAway Instrument REF B1018-496
FDA Device · Class II · 2022-05-25 · Beckman Coulter - MicroScan WalkAway-40 plus Instrument REF B1018-283
FDA Device · Class II · 2022-05-25 · Beckman Coulter - Beckman Coulter IRISpec CA/CB/CC control, Catalog #800-7211, containing 3 x 100 mL bottles each of CA Control, CB Control, and CC Control
FDA Device · Class III · 2022-04-27 · Beckman Coulter - AU/DxC AU Magnesium, Catalog/REF Number OSR6189, UDI 15099590010850
FDA Device · Class II · 2022-03-09 · Beckman Coulter - SYNCHRON Systems Cholesterol (CHOL) Reagent, REF: 467825
FDA Device · Class II · 2021-12-29 · Beckman Coulter - Power Processor 3K, 3K High Speed Stockyards Module Nameplate: PP 3K Stockyard (Refrig) 9707 REF A88116
FDA Device · Class II · 2021-10-20 · Beckman Coulter - Access hsTnI High Sensitivity Troponin I, REF B52699 Access Immunoassay System REAGENT PACK
FDA Device · Class II · 2021-10-13 · Beckman Coulter - DxA 5000 (DxA Automation System, DxA 5000 fit), "For in Vitro Diagnostic Use", Reference Numbers: B87352 with B57634, UDI: 15099590707118
FDA Device · Class II · 2021-10-06 · Beckman Coulter - Access SARS CoV-2 IgG (1st IS) Assay: Access Immunoassay Systems REAGENT PACK, REF C74339 Access SARS-CoV-2 IgG (1st IS) Calibrators, REF C…
FDA Device · Class II · 2021-09-29 · Beckman Coulter - Normand Remisol Advance Data Manager, REF: C69412, C69413, C44703, and C57017 is a software device that interfaces between laboratory infor…
FDA Device · Class II · 2021-09-01 · Beckman Coulter - 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 Device · Class II · 2021-08-18 · Beckman Coulter - 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…
FDA Device · Class II · 2021-08-18 · Beckman Coulter - ACCESS SARS-CoV-2 ANTIGEN EXTRACTION SOLUTION, CONTENTS: 6 x 6.0 mL EXTRACTION SOLN, IVD, Rx Only, UDI: (01)15099590743017
FDA Device · Class II · 2021-08-18 · Beckman Coulter - ACCESS SARS-CoV-2 Antigen , REF: C68668, IVD, Rx only, UDI: (01) 15099590742713
FDA Device · Class II · 2021-08-18 · Beckman Coulter - Access SARS-CoV-2 Antigen Calibrators, Catalog, REF: C68669, Contents: 1x2.5 mL C0, 1x2.5mL C1, 1x CAL CARD, UDI: (01)15099590742720
FDA Device · Class II · 2021-08-18 · Beckman Coulter - Access SARS CoV-2 lgG II Reagent, REF: C69057, IVD CE UDI: (01)15099590742744
FDA Device · Class II · 2021-06-30 · Beckman Coulter - Access SARS-CoV-2 lgG II Calibrator, REF C69058, IVD, CE UDI: (01)15099590742751
FDA Device · Class II · 2021-06-30 · Beckman Coulter - 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 Device · Class II · 2021-06-02 · Beckman Coulter - MicroScan WalkAway-96 plus Reconditioned Instrument
FDA Device · Class II · 2021-04-14 · Beckman Coulter - MicroScan WalkAway-40 plus Reconditioned Instrument
FDA Device · Class II · 2021-04-14 · Beckman Coulter - MicroScan WalkAway-96 plus Instrument
FDA Device · Class II · 2021-04-14 · Beckman Coulter - MicroScan WalkAway-40 plus Instrument
FDA Device · Class II · 2021-04-14 · Beckman Coulter - ACCESS SARS-CoV-2 IgG QC SARS-CoV-2 IgG REF C58964 - Product Usage: use on the Access Family of Immunoassay Systems only
FDA Device · Class II · 2021-01-27 · Beckman Coulter - MicroScan Pos MIC Panel Type 34 - Product Usage: For the determination of antimicrobial agent susceptibility and/or identification to the s…
FDA Device · Class II · 2020-12-30 · Beckman Coulter - UIBC
FDA Device · Class II · 2020-10-07 · Beckman Coulter - BECKMAN COULTER ACCESS Immunoassay Systems - Access Unconjugated Estriol, REF 33570
FDA Device · Class II · 2020-09-30 · Beckman Coulter - Beckman Coulter ACCESS Immunoassay Systems, Access GI Monitor Cancer Antigen 19-9, REF 387687 ( UDI: 15099590231842) the Access Family of I…
FDA Device · Class II · 2020-06-10 · Beckman Coulter - Beckman Coulter ACCESS Immunoassay Systems, Access Total T3 Triiodothyronine , REF 33830 (UDI: 15099590227210) for use with the Access Fami…
FDA Device · Class II · 2020-06-10 · Beckman Coulter - Beckman Coulter ACCESS Immunoassay Systems, Access Thyroglobulin, REF 33860 (UDI: 15099590227173) for use with the Access Family of Immunoa…
FDA Device · Class II · 2020-06-10 · Beckman Coulter - Beckman Coulter Access Immunoassay Systems, Access Free T4 Thyroxine, REF 33880 (UDI:15099590225834) for use with Access Family of Immunoas…
FDA Device · Class II · 2020-06-10 · Beckman Coulter - Beckman Coulter ACCESS Immunoassay Systems, Access Thyroglobulin Antibody II, REF A32898 (UDI: 15099590202910) for use with the Access Fami…
FDA Device · Class II · 2020-06-10 · Beckman Coulter - Beckman Coulter Access Immunoassay Systems, Access Free T3 Triiodothyronine, REF A13422 (UDI: 15099590201661) for use with the Access Famil…
FDA Device · Class II · 2020-06-10 · Beckman Coulter - ISE Electrolyte Reference (2 X 2L) Reagent, REF A28937, UDI: 15099590202491 - Product Usage: are intended for the quantitative determinatio…
FDA Device · Class II · 2020-06-03 · Beckman Coulter - iQ200 Series Urine Microscopy Analyzer- All part numbers
FDA Device · Class II · 2020-05-20 · Beckman Coulter - iChem¿VELOCITY Urine Chemistry System-
FDA Device · Class II · 2020-05-20 · Beckman Coulter - SYNCHRON Systems Barbiturates Reagent (BARB 1 X 250)
FDA Device · Class II · 2020-05-06 · Beckman Coulter - Synchron Systems Opiate 2000 ng Reagent (OP2 1 x 250)
FDA Device · Class II · 2020-04-29 · Beckman Coulter - Opiate 300 Ng Reagent (OP 1 X 250) for use in conjunction with UniCel DxC 600/800 System(s) and SYNCHRON Systems OP 300 Urine Calibrators,…
FDA Device · Class II · 2020-04-29 · Beckman Coulter - Beckman Coulter Power Express Sample Processing System AU5800XL connection unit, catalog #B36351
FDA Device · Class II · 2020-04-29 · Beckman Coulter - LabPro Data Management System, UDI: 15099590676872 - Product Usage: The LabPro Data Management System is a Microsoft Windows based software…
FDA Device · Class II · 2020-04-15 · Beckman Coulter - Beckman Coulter MicroScan PROMPT Inoculation System-D, Catalog Number B1026-10D, UDI: 15099590659561 - Product Usage: The Prompt Inoculatio…
FDA Device · Class II · 2020-04-15 · Beckman Coulter - iChemVELOCITY Strips, Catalog 800-7212
FDA Device · Class II · 2020-04-01 · Beckman Coulter - Uric Acid Reagent (URIC 2 X 300), REF: 442785, For In Vitro Diagnostic Use, Rx Only, UDI: 15099590575281
FDA Device · Class II · 2020-03-11 · Beckman Coulter - Enzymatic Creatinine Reagent (CR-E 2 X 200), REF A60298, For in Vitro Diagnostic Use, Rx Only, UDI: 15099590625733
FDA Device · Class II · 2020-03-11 · Beckman Coulter - Direct Bilirubin Reagents (DBIL 2 x 200 ) and (DBIL 2 x 300), Ref:439715 (200 tests/cartridge) and 476856 (300 tests/cartridge), For In Vit…
FDA Device · Class II · 2020-03-11 · Beckman Coulter - 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…
FDA Device · Class II · 2020-03-11 · Beckman Coulter - Triglycerides Reagent (TG 2 x 300), REF: 445850, For In Vitro Diagnostic Use, Rx Only, UDI: 15099590233228
FDA Device · Class II · 2020-03-11 · Beckman Coulter - iChemVELOCITY, Urine Chemistry System, Catalog numbers: 700-7176-001, 700-7177-001, B75502 - Product Usage: used to automate the urine chem…
FDA Device · Class II · 2020-02-05 · Beckman Coulter - iQ200 Series Urine Microscopy Analyzer, Catalog numbers: 700-3345, 700-3375, 700-3325, 700-3347, 700-3300RFB, 700- 3320, 700-3320RFB, 700-3…
FDA Device · Class II · 2020-02-05 · Beckman Coulter - iChem VELOCITY Urine Chemistry Analyzer
FDA Device · Class II · 2020-01-29 · Beckman Coulter