Beckman Coulter, Inc.
Beckman Coulter, Inc. appears in FDA public data with 330 recalls — including 5 Class I (most serious) —, 278 510(k) clearances, 27 FDA inspections, and 4 compliance actions on record. Its most recent recall (Z-1922-2026, Class II) was initiated on March 16, 2026. Its most recent 510(k) clearance was granted on March 24, 2026.
Summary
- Total Recalls
- 330 (5 Class I)
- 510(k) Clearances
- 278
- Inspections
- 27
- Compliance Actions
- 4
Known Names
beckman coulter, beckman coulter biomedical, beckman coulter ireland, beckman coulter mishima k.k
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-1922-2026 | Class II | Access Total T4 Calibrator, Catalog No. 33805 | March 16, 2026 |
| Z-1235-2026 | Class II | CellMek SPS Sample Preparation System, REF: C44603, with software | December 23, 2025 |
| Z-1026-2026 | Class II | Beckman Coulter UniCel Dxl 800, Part numbers: 973100, A71456, A71457, A25288; Immunoassay Method, | November 26, 2025 |
| Z-1025-2026 | Class II | Beckman Coulter UniCel Dxl 600, Part numbers: A71460, A71461, A30260; Immunoassay Method, Troponin | November 26, 2025 |
| Z-1221-2026 | Class II | COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For use as an isotonic buffer | November 10, 2025 |
| Z-0889-2026 | Class II | Access 2 Reaction Vessels, individual, disposable, plastic tubes used to process patient, quality co | November 7, 2025 |
| Z-0428-2026 | Class II | Beckman Coulter UniCel DxI 600, Part Numbers: A71460, A30260; Photometric Chemistry Analyzer | October 1, 2025 |
| Z-0429-2026 | Class II | Beckman Coulter UniCel DxI 800, Part Numbers: 973100, A71456; Photometric Chemistry Analyzer | October 1, 2025 |
| Z-0541-2026 | Class II | DxFLEX Flow Cytometer Catalog Number C78500 UDI-DI code: 15099590754013 The DxFLEX Flow Cytomete | September 22, 2025 |
| Z-0215-2026 | Class II | DxC 500i Clinical Analyzer Modules, DxC 500 AU Module w/ISE, DxC 500i (Part Number C63522), DxC 500 | September 19, 2025 |
| Z-0216-2026 | Class II | DxI 9000 Access Immunoassay Analyzer, Part Number C11137 | September 19, 2025 |
| Z-0441-2026 | Class II | SYNCHRON Systems Direct LDL Cholesterol (LDLD) Reagent, REF: 969706 | September 17, 2025 |
| Z-1794-2026 | Class II | MicroScan Neg Multidrug Resistant MIC 1 REF C32368 UDI-DI code: 15099590720568 Intended Use- For | September 8, 2025 |
| Z-0412-2026 | Class II | CellMek SPS Sample Preparation System, REF: C44603. Software versions 2.2.122.0 and prior, and Instr | September 8, 2025 |
| Z-0071-2026 | Class II | SYNCHRON Systems Phosphorus (PHOSm) Reagent REF: 467868 For In Vitro Diagnostic Use, Rx Only. | September 3, 2025 |
| Z-2575-2025 | Class II | UniCel DxH 600 COULTER Cellular Analysis System, configured with the Led HGB Photometer REF:B23858 | August 13, 2025 |
| Z-2574-2025 | Class II | UniCel DxH 800 COULTER Cellular Analysis System, configured with the Led HGB Photometer REFs:B24802 | August 13, 2025 |
| Z-2573-2025 | Class II | UniCel DxH 690T COULTER Cellular Analysis System, configured with the Led HGB Photometer REF: C3452 | August 13, 2025 |
| Z-2572-2025 | Class II | UniCel DxH 900 COULTER Cellular Analysis System, configured with the Led HGB Photometer REF: C11478 | August 13, 2025 |
| Z-0032-2026 | Class II | DxC 500 AU Module w/ISE, DxC 500i, With ISE, REF: C63522 and DxC 500 AU Module, DxC 500i, Without IS | August 4, 2025 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K252169 | Access BNP II | March 24, 2026 |
| K254059 | Access anti-HBc IgM | March 13, 2026 |
| K253687 | Access anti-HBc Total | February 19, 2026 |
| K251995 | Access anti-HAV IgM | January 27, 2026 |
| K250588 | Access Rubella IgG | November 17, 2025 |
| K252580 | iQ200 Series | September 10, 2025 |
| K243846 | Access anti-HAV | September 9, 2025 |
| K243804 | MicroScan Dried Gram-Negative MIC/Combo Panels with Cefepime (CPE) (0.12-64 µg/mL) (MicroScan) | August 20, 2025 |
| K250036 | MicroScan Dried Gram-Positive MIC/Combo Panels with Daptomycin (DAP) (0.06-32 µg/mL) | August 15, 2025 |
| K243483 | Access hsTnI | August 1, 2025 |
| K250084 | MicroScan Dried Gram-Negative MIC/Combo Panels with Aztreonam (AZT) (0.5-64 µg/mL) | July 18, 2025 |
| K242870 | Access hsTnI | June 16, 2025 |
| K242022 | Access Toxo IgG | March 28, 2025 |
| K242190 | Access Cortisol; DxC 500i Clinical Analyzer | March 5, 2025 |
| K242095 | Access Toxo IgM II | October 11, 2024 |
| K241427 | Access Syphilis | September 6, 2024 |
| K240469 | Access TPO Antibody | August 9, 2024 |
| K240252 | UniCel DxH 900 Coulter Cellular Analysis System; UniCel DxH Slidemaker Stainer II Coulter Cellular A | July 5, 2024 |
| K240987 | Access sTfR | July 3, 2024 |
| K240996 | Access Thyroglobulin Antibody II | July 3, 2024 |