Beckman Coulter recalls
Beckman Coulter appears in 338 official U.S. recall notices indexed by RecallRadar, most recently on 2026-10-21.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
- IQ200 SPRINT, REF: 700-3322,700-3322RFB, 700-3325, 700-3326, B48997
FDA Device · Class II · 2026-10-21 · Beckman Coulter - DxU 840m Iris, REF: C76947
FDA Device · Class II · 2026-10-21 · Beckman Coulter - DxC 500 AU Clinical Chemistry Analyzers: 1. AU w/out ISE, Part No. C63519 2. AU w/ISE, Part No. C63520
FDA Device · Class II · 2026-10-14 · Beckman Coulter - DxC 500i Clinical Analyzer Modules: 1. DxC 500 AU Module w/ISE, DxC 500i, Part No. C63522 2. DxC 500 AU Module, DxC 500i, Part No. C63521 3…
FDA Device · Class II · 2026-10-14 · Beckman Coulter - Beckman Coulter DxC 500i Clinical Analyzer Modules using software version 1.5 or lower: 1) DxC 500 AU Module w/ISE, DxC 500i, Part Number C…
FDA Device · Class II · 2026-08-26 · Beckman Coulter - Beckman Coulter DxC 500 AU Clinical Analyzer Modules using software version 1.5 or lower: 1) AU w/out ISE, Part Number C63519
FDA Device · Class II · 2026-08-26 · Beckman Coulter - REF # D23354, MicroScan LabPro V5.03 Panel Update 11 DVD Kit (US) on the following instruments: - B1018-280 MicroScan autoSCAN-4 Instrument…
FDA Device · Class II · 2026-08-12 · Beckman Coulter - REF # D23352, MicroScan LabPro V5.03 Panel Update 11 (US), Electronic installed on the following instruments: - B1018-280 MicroScan autoSCA…
FDA Device · Class II · 2026-08-12 · Beckman Coulter - Access Total T4 Calibrator, Catalog No. 33805
FDA Device · Class II · 2026-04-29 · Beckman Coulter - MicroScan Neg MIC 3J REF C54814
FDA Device · Class II · 2026-04-15 · Beckman Coulter - MicroScan Neg Multidrug Resistant MIC 1 REF C32368 UDI-DI code: 15099590720568 Intended Use- For use with MicroScan Dried Gram Negative MIC…
FDA Device · Class II · 2026-04-15 · Beckman Coulter - MicroScan Neg MIC 56 REF C42464 UDI-DI code: 15099590731212 MicroScan panels are designed for use in determining antimicrobial agent suscep…
FDA Device · Class II · 2026-04-01 · Beckman Coulter - CellMek SPS Sample Preparation System, REF: C44603, with software
FDA Device · Class II · 2026-02-11 · Beckman Coulter - COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For use as an isotonic buffered diluent in conjunction with a cyanide-fr…
FDA Device · Class II · 2026-02-11 · Beckman Coulter - Beckman Coulter UniCel Dxl 800, Part numbers: 973100, A71456, A71457, A25288
FDA Device · Class II · 2026-01-14 · Beckman Coulter - Beckman Coulter UniCel Dxl 600, Part numbers: A71460, A71461, A30260
FDA Device · Class II · 2026-01-14 · Beckman Coulter - Access 2 Reaction Vessels, individual, disposable, plastic tubes used to process patient, quality control and calibration samples on the Ac…
FDA Device · Class II · 2025-12-17 · Beckman Coulter - DxFLEX Flow Cytometer Catalog Number C78500 UDI-DI code: 15099590754013 The DxFLEX Flow Cytometer is intended for use as an in vitro diagno…
FDA Device · Class II · 2025-11-26 · Beckman Coulter - Beckman Coulter UniCel DxI 600, Part Numbers: A71460, A30260
FDA Device · Class II · 2025-11-12 · Beckman Coulter - Beckman Coulter UniCel DxI 800, Part Numbers: 973100, A71456
FDA Device · Class II · 2025-11-12 · Beckman Coulter - SYNCHRON Systems Direct LDL Cholesterol (LDLD) Reagent, REF: 969706
FDA Device · Class II · 2025-11-12 · Beckman Coulter - CellMek SPS Sample Preparation System, REF: C44603
FDA Device · Class II · 2025-11-05 · Beckman Coulter - DxC 500i Clinical Analyzer Modules, DxC 500 AU Module w/ISE, DxC 500i (Part Number C63522), DxC 500 AU Module, DxC 500i (Part Number C63521…
FDA Device · Class II · 2025-10-29 · Beckman Coulter - DxI 9000 Access Immunoassay Analyzer, Part Number C11137
FDA Device · Class II · 2025-10-29 · Beckman Coulter - SYNCHRON Systems Phosphorus (PHOSm) Reagent REF: 467868 For In Vitro Diagnostic Use, Rx Only
FDA Device · Class II · 2025-10-15 · Beckman Coulter - DxC 500 AU Module w/ISE, DxC 500i, With ISE, REF: C63522 and DxC 500 AU Module, DxC 500i, Without ISE, REF: C6352
FDA Device · Class II · 2025-10-08 · Beckman Coulter - UniCel DxH 900 COULTER Cellular Analysis System, configured with the Led HGB Photometer REF: C11478
FDA Device · Class II · 2025-09-24 · Beckman Coulter - UniCel DxH 690T COULTER Cellular Analysis System, configured with the Led HGB Photometer REF: C34520
FDA Device · Class II · 2025-09-24 · Beckman Coulter - UniCel DxH 800 COULTER Cellular Analysis System, configured with the Led HGB Photometer REFs:B24802, 629029, B63322
FDA Device · Class II · 2025-09-24 · Beckman Coulter - UniCel DxH 600 COULTER Cellular Analysis System, configured with the Led HGB Photometer REF:B23858
FDA Device · Class II · 2025-09-24 · Beckman Coulter - Access Thyroglobulin assay, a simultaneous one-step immunoenzymatic assay, Catalog Number 33860
FDA Device · Class II · 2025-08-20 · Beckman Coulter - DxI 600 Access Immunoassay Analyzer W/Dual Gantry, Part Number A71461
FDA Device · Class II · 2025-08-13 · Beckman Coulter - UniCel DxI 600 Access Immunoassay Analyzer, Part Number A30260
FDA Device · Class II · 2025-08-13 · Beckman Coulter - DxI 800 Access Immunoassay Analyzer W/Dual Gantry, Part Number A71457
FDA Device · Class II · 2025-08-13 · Beckman Coulter - DxI 600 Access Immunoassay Analyzer W/Spot B, Part Number A71460
FDA Device · Class II · 2025-08-13 · Beckman Coulter - UIBC (Unsaturated Iron Binding Capacity), REF: OSR61205
FDA Device · Class II · 2025-08-13 · Beckman Coulter - DxI 800 Access Immunoassay Analyzer W/Spot B, Part Number A71456
FDA Device · Class II · 2025-08-13 · Beckman Coulter - UniCel DxI 800 Access Immunoassay Analyzer, Part Number 973100
FDA Device · Class II · 2025-08-13 · Beckman Coulter - Estrone RIA, REF: DSL8700
FDA Device · Class II · 2025-07-30 · Beckman Coulter - Access Vitamin B12 Reagent, Catalog Number 33000, Lot Number 439850
FDA Device · Class II · 2025-07-23 · Beckman Coulter - REMISOL Advance UDI-DI code: 13700962601874 All Software Versions: B92487
FDA Device · Class II · 2025-07-02 · Beckman Coulter - DxI 9000 Access Immunoassay Analyzer C11137
FDA Device · Class II · 2025-07-02 · Beckman Coulter - DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, running software versions 1.20
FDA Device · Class II · 2025-06-18 · Beckman Coulter - Access Testosterone assay, Catalog Number 33560
FDA Device · Class II · 2025-06-11 · Beckman Coulter - DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, running software version 1.20
FDA Device · Class II · 2025-06-11 · Beckman Coulter - DxC 500 AU Clinical Chemistry Analyzer, Catalog Numbers/UDI codes: C63519 / 14987666545058 C63520 / 14987666545065
FDA Device · Class II · 2025-05-21 · Beckman Coulter - DxC 500 AU Clinical Chemistry Analyzer, Catalog Numbers/UDI codes: C63519 / 14987666545058 C63520 / 14987666545065 Software versions: V1.3,…
FDA Device · Class II · 2025-05-07 · Beckman Coulter - Beckman Coulter DxI 9000 Access Immunoassay Analyzer
FDA Device · Class II · 2025-04-30 · Beckman Coulter - DxI 9000 Access Immunoassay Analyzer, catalog number C11137 in vitro diagnostic device used for the quantitative, semi-quantitative, or qua…
FDA Device · Class II · 2025-04-16 · Beckman Coulter - DxC 500 AU Clinical Chemistry Analyzer, Catalog Numbers/UDI codes: C63519 / 14987666545058 C63520 / 14987666545065 The Beckman Coulter DxC…
FDA Device · Class II · 2025-04-09 · Beckman Coulter