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Is Beckman Coulter recalled?

Beckman Coulter recalls - full list & free alerts

Official U.S. agency records list 20 recalls involving Beckman Coulter in the last 12 months, most recently on 2026-08-26. Check each official notice for the exact products, lot codes and dates affected.

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Recalls (20)

Beckman Coulter Inc.: 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
Medical DevicesFDA (device) · 2026-08-26 · Class II
Beckman Coulter Inc.: Beckman Coulter DxC 500 AU Clinical Analyzer Modules using software version 1.5 or lower: 1) AU w/out ISE, Part Number C63519; 2) AU w/
Medical DevicesFDA (device) · 2026-08-26 · Class II
Beckman Coulter Inc.: REF # D23352, MicroScan LabPro V5.03 Panel Update 11 (US), Electronic installed on the following instruments: - B1018-280 MicroScan autoS
Medical DevicesFDA (device) · 2026-08-12 · Class II
Beckman Coulter Inc.: REF # D23354, MicroScan LabPro V5.03 Panel Update 11 DVD Kit (US) on the following instruments: - B1018-280 MicroScan autoSCAN-4 Instrumen
Medical DevicesFDA (device) · 2026-08-12 · Class II
Beckman Coulter, Inc.: Access Total T4 Calibrator, Catalog No. 33805
Medical DevicesFDA (device) · 2026-04-29 · Class II
Beckman Coulter, Inc.: MicroScan Neg MIC 3J REF C54814
Medical DevicesFDA (device) · 2026-04-15 · Class II
Beckman Coulter, Inc.: MicroScan Neg Multidrug Resistant MIC 1 REF C32368 UDI-DI code: 15099590720568 Intended Use- For use with MicroScan Dried Gram Negative
Medical DevicesFDA (device) · 2026-04-15 · Class II
Beckman Coulter, Inc.: MicroScan Neg MIC 56 REF C42464 UDI-DI code: 15099590731212 MicroScan panels are designed for use in determining antimicrobial agent sus
Medical DevicesFDA (device) · 2026-04-01 · Class II
Beckman Coulter, Inc.: COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For use as an isotonic buffered diluent in conjunction with a cyanide
Medical DevicesFDA (device) · 2026-02-11 · Class II
Beckman Coulter, Inc.: CellMek SPS Sample Preparation System, REF: C44603, with software
Medical DevicesFDA (device) · 2026-02-11 · Class II
Beckman Coulter, Inc.: Beckman Coulter UniCel Dxl 600, Part numbers: A71460, A71461, A30260; Immunoassay Method, Troponin Subunit
Medical DevicesFDA (device) · 2026-01-14 · Class II
Beckman Coulter, Inc.: Beckman Coulter UniCel Dxl 800, Part numbers: 973100, A71456, A71457, A25288; Immunoassay Method, Troponin Subunit
Medical DevicesFDA (device) · 2026-01-14 · Class II
Beckman Coulter, Inc.: Access 2 Reaction Vessels, individual, disposable, plastic tubes used to process patient, quality control and calibration samples on the Acc
Medical DevicesFDA (device) · 2025-12-17 · Class II
Beckman Coulter Inc.: DxFLEX Flow Cytometer Catalog Number C78500 UDI-DI code: 15099590754013 The DxFLEX Flow Cytometer is intended for use as an in vitro dia
Medical DevicesFDA (device) · 2025-11-26 · Class II
Beckman Coulter, Inc.: Beckman Coulter UniCel DxI 600, Part Numbers: A71460, A30260; Photometric Chemistry Analyzer
Medical DevicesFDA (device) · 2025-11-12 · Class II
Beckman Coulter, Inc.: Beckman Coulter UniCel DxI 800, Part Numbers: 973100, A71456; Photometric Chemistry Analyzer
Medical DevicesFDA (device) · 2025-11-12 · Class II
Beckman Coulter Inc.: SYNCHRON Systems Direct LDL Cholesterol (LDLD) Reagent, REF: 969706
Medical DevicesFDA (device) · 2025-11-12 · Class II
Beckman Coulter, Inc.: CellMek SPS Sample Preparation System, REF: C44603. Software versions 2.2.122.0 and prior, and Instructions for Use (IFU) revisions AD and p
Medical DevicesFDA (device) · 2025-11-05 · Class II
Beckman Coulter, Inc.: 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)
Medical DevicesFDA (device) · 2025-10-29 · Class II
Beckman Coulter, Inc.: DxI 9000 Access Immunoassay Analyzer, Part Number C11137
Medical DevicesFDA (device) · 2025-10-29 · Class II
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