Beckman Coulter, Inc. recalls

57 recalls on record · latest: March 16, 2026

Official U.S. recall history for Beckman Coulter, Inc., compiled from official government records.

Get recall alerts

Free email alert whenever Beckman Coulter, Inc. has a new recall — straight from official government data. Unsubscribe anytime.

Beckman Coulter, Inc. recalls Access Total T4 Calibrator, Catalog No. 33805

March 16, 2026 · Medical device recalls Moderate risk Beckman Coulter has identified that Access Total T4 Calibrator lots (PN 33805)…

Beckman Coulter, Inc. recalls CellMek SPS Sample Preparation System, REF: C44603, with software

December 23, 2025 · Medical device recalls Moderate risk Sample preparation system designed to automate staining, lysing, cell washing h…

Beckman Coulter, Inc. recalls Beckman Coulter UniCel Dxl 800, Part numbers: 973100, A71456, A71457, A25288; Immunoassay Method, Troponin Subunit

November 26, 2025 · Medical device recalls Moderate risk Beckman Coulter has determined that, due to a potential communication issue, th…

Beckman Coulter, Inc. recalls Beckman Coulter UniCel Dxl 600, Part numbers: A71460, A71461, A30260; Immunoassay Method, Troponin Subunit

November 26, 2025 · Medical device recalls Moderate risk Beckman Coulter has determined that, due to a potential communication issue, th…

Beckman Coulter, Inc. recalls COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For use as an isotonic buffered diluent in conjuncti…

November 10, 2025 · Medical device recalls Moderate risk Due to specific lots of diluents contributing to elevated platelet Daily Checks…

Beckman Coulter, Inc. recalls Access 2 Reaction Vessels, individual, disposable, plastic tubes used to process patient, quality control and calibrati…

November 7, 2025 · Medical device recalls Moderate risk It has been determined that certain lots of Access 2 Reaction Vessels may conta…

Beckman Coulter, Inc. recalls Beckman Coulter UniCel DxI 800, Part Numbers: 973100, A71456; Photometric Chemistry Analyzer

October 1, 2025 · Medical device recalls Moderate risk An internal investigation has determined that due to defective sub-components w…

Beckman Coulter, Inc. recalls Beckman Coulter UniCel DxI 600, Part Numbers: A71460, A30260; Photometric Chemistry Analyzer

October 1, 2025 · Medical device recalls Moderate risk An internal investigation has determined that due to defective sub-components w…

Beckman Coulter product recalled over injury risk

September 22, 2025 · Medical device recalls Moderate risk Due to a software error code that crashes during acquisition on patient sample…

Beckman Coulter, Inc. recalls DxC 500i Clinical Analyzer Modules, DxC 500 AU Module w/ISE, DxC 500i (Part Number C63522), DxC 500 AU Module, DxC 500i…

September 19, 2025 · Medical device recalls Moderate risk Beckman Coulter has confirmed a software anomaly on DxI 9000 Access Immunoassay…

Beckman Coulter, Inc. recalls DxI 9000 Access Immunoassay Analyzer, Part Number C11137

September 19, 2025 · Medical device recalls Moderate risk Beckman Coulter has confirmed a software anomaly on DxI 9000 Access Immunoassay…

Beckman Coulter Inc. recalls SYNCHRON Systems Direct LDL Cholesterol (LDLD) Reagent, REF: 969706

September 17, 2025 · Medical device recalls Moderate risk Beckman Coulter has identified that there is an increased probability Synchron…

Beckman Coulter, Inc. recalls MicroScan Neg Multidrug Resistant MIC 1 REF C32368 UDI-DI code: 15099590720568 Intended Use- For use with MicroScan Dri…

September 8, 2025 · Medical device recalls Moderate risk Due to manufacturing issue (incorrectly processing) with in vitro multidrug res…

Beckman Coulter, Inc. recalls CellMek SPS Sample Preparation System, REF: C44603. Software versions 2.2.122.0 and prior, and Instructions for Use (IF…

September 8, 2025 · Medical device recalls Moderate risk Automated pipetting, diluting and specimen processing workstations for flow cyt…

Beckman Coulter Inc. recalls SYNCHRON Systems Phosphorus (PHOSm) Reagent REF: 467868 For In Vitro Diagnostic Use, Rx Only.

September 3, 2025 · Medical device recalls Moderate risk Specific SYNCHRON Systems Modular Chemistry Phosphorus (PHOSm REF 467868) reage…

Beckman Coulter Inc. recalls UniCel DxH 600 COULTER Cellular Analysis System, configured with the Led HGB Photometer REF:B23858

August 13, 2025 · Medical device recalls Moderate risk Hematology analyzers configured with HGB photometers may result in erroneously…

Beckman Coulter Inc. recalls UniCel DxH 690T COULTER Cellular Analysis System, configured with the Led HGB Photometer REF: C34520

August 13, 2025 · Medical device recalls Moderate risk Hematology analyzers configured with HGB photometers may result in erroneously…

Beckman Coulter Inc. recalls UniCel DxH 900 COULTER Cellular Analysis System, configured with the Led HGB Photometer REF: C11478

August 13, 2025 · Medical device recalls Moderate risk Hematology analyzers configured with HGB photometers may result in erroneously…

Beckman Coulter Inc. recalls UniCel DxH 800 COULTER Cellular Analysis System, configured with the Led HGB Photometer REFs:B24802, 629029, B63322

August 13, 2025 · Medical device recalls Moderate risk Hematology analyzers configured with HGB photometers may result in erroneously…

Beckman Coulter Inc. recalls DxC 500 AU Module w/ISE, DxC 500i, With ISE, REF: C63522 and DxC 500 AU Module, DxC 500i, Without ISE, REF: C6352; part…

August 4, 2025 · Medical device recalls Moderate risk On a clinical analyzer, when ordering a Clinical Chemistry (CC) combination tes…

Beckman Coulter, Inc. recalls MicroScan Neg MIC 56 REF C42464 UDI-DI code: 15099590731212 MicroScan panels are designed for use in determining antimi…

July 24, 2025 · Medical device recalls Moderate risk Due to the likely presence of contamination in well(s).

Beckman Coulter, Inc. recalls Access Thyroglobulin assay, a simultaneous one-step immunoenzymatic assay, Catalog Number 33860

July 10, 2025 · Medical device recalls Moderate risk Access Thyroglobulin reagent lot 439163 may generate erroneously high patient r…

Beckman Coulter Inc. recalls UIBC (Unsaturated Iron Binding Capacity), REF: OSR61205,

June 26, 2025 · Medical device recalls Moderate risk Beckman Coulter identified that the Unsaturated Iron Binding Capacity (UIBC) as…

Beckman Coulter, Inc. recalls MicroScan Neg MIC 3J REF C54814

June 25, 2025 · Medical device recalls Moderate risk Due to a manufacturing issue - missing a drug in well 4/4 but contain double th…