Countries where the notices were issued: United States (32).
Name as written in the notices: Beckman Coulter, Inc.; Beckman Coulter Inc.. This is the brand or the responsible company as each authority recorded it. A recall shows a safety system working; it is not a verdict on a brand. Follow the official notice for each product.
| Date | Authority | Product | Hazard (as classified) |
|---|
| 2026-09-02 | US FDA — Medical Devices | DxC 500i Clinical Analyzer Modules: 1. DxC 500 AU Module w/ISE, DxC 500i, Part No. C63522 2. DxC 500 AU Module, Dx | — |
| 2026-09-02 | US FDA — Medical Devices | DxC 500 AU Clinical Chemistry Analyzers: 1. AU w/out ISE, Part No. C63519 2. AU w/ISE, Part No. C63520 | — |
| 2026-07-15 | US FDA — Medical Devices | Beckman Coulter DxC 500 AU Clinical Analyzer Modules using software version 1.5 or lower: 1) AU w/out ISE, Part Numbe | — |
| 2026-07-15 | US FDA — Medical Devices | Beckman Coulter DxC 500i Clinical Analyzer Modules using software version 1.5 or lower: 1) DxC 500 AU Module w/ISE, D | — |
| 2026-03-16 | US FDA — Medical Devices | Access Total T4 Calibrator, Catalog No. 33805 | — |
| 2025-11-26 | US FDA — Medical Devices | Beckman Coulter UniCel Dxl 600, Part numbers: A71460, A71461, A30260; Immunoassay Method, Troponin Subunit | — |
| 2025-11-26 | US FDA — Medical Devices | Beckman Coulter UniCel Dxl 800, Part numbers: 973100, A71456, A71457, A25288; Immunoassay Method, Troponin Subunit | — |
| 2025-11-07 | US FDA — Medical Devices | Access 2 Reaction Vessels, individual, disposable, plastic tubes used to process patient, quality control and calibratio | — |
| 2025-10-01 | US FDA — Medical Devices | Beckman Coulter UniCel DxI 600, Part Numbers: A71460, A30260; Photometric Chemistry Analyzer | — |
| 2025-09-19 | US FDA — Medical Devices | DxI 9000 Access Immunoassay Analyzer, Part Number C11137 | — |
| 2025-09-08 | US FDA — Medical Devices | CellMek SPS Sample Preparation System, REF: C44603. Software versions 2.2.122.0 and prior, and Instructions for Use (IFU | — |
| 2025-08-04 | US FDA — Medical Devices | DxC 500 AU Module w/ISE, DxC 500i, With ISE, REF: C63522 and DxC 500 AU Module, DxC 500i, Without ISE, REF: C6352; part | — |
| 2025-06-26 | US FDA — Medical Devices | UIBC (Unsaturated Iron Binding Capacity), REF: OSR61205, | — |
| 2025-06-25 | US FDA — Medical Devices | DxI 800 Access Immunoassay Analyzer W/Dual Gantry, Part Number A71457 | — |
| 2025-06-25 | US FDA — Medical Devices | DxI 600 Access Immunoassay Analyzer W/Spot B, Part Number A71460 | — |
| 2025-06-25 | US FDA — Medical Devices | DxI 800 Access Immunoassay Analyzer W/Spot B, Part Number A71456 | — |
| 2025-06-25 | US FDA — Medical Devices | DxI 600 Access Immunoassay Analyzer W/Dual Gantry, Part Number A71461 | — |
| 2025-06-12 | US FDA — Medical Devices | Estrone RIA, REF: DSL8700. Estrone RIA is an IVD used for the quantitative measurement of estrone in human serum and pl | — |
| 2025-04-08 | US FDA — Medical Devices | REMISOL Advance UDI-DI code: 13700962601874 All Software Versions: B92487; B92488; C24317; C28652; C37500; D04164; C4 | — |
| 2025-03-20 | US FDA — Medical Devices | DxC 500 AU Clinical Chemistry Analyzer, Catalog Numbers/UDI codes: C63519 / 14987666545058 C63520 / 14987666545065. | — |
| 2025-02-27 | US FDA — Medical Devices | Access Vitamin B12 Reagent, Catalog Number 33000, Lot Number 439850 | — |
| 2025-02-03 | US FDA — Medical Devices | Access Erythropoietin (EPO), Catalog Number - A16364 a glycoprotein (~30,400 Daltons) produced primarily by the kidney, | — |
| 2025-01-02 | US FDA — Medical Devices | Access PCT Reagent Pack, Catalog Number C53987, when used on Access 2 and UniCel Dxl Immunoassay Systems | — |
| 2024-11-26 | US FDA — Medical Devices | Access Intact PTH assay, a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of int | — |
| 2024-11-18 | US FDA — Medical Devices | Access hsTnI Reagent, REF B52699, Immunoassay Method, Troponin Subunit. For the quantitative determination of cardiac t | — |
| 2024-11-13 | US FDA — Medical Devices | DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137 | — |
| 2024-07-16 | US FDA — Medical Devices | Beckman Coulter IRISPEC CA/CB/CC Urine Chemistry Controls, Catalog Number REF 800-7211 and 800-7702, in vitro diagnostic | — |
| 2024-07-10 | US FDA — Medical Devices | Beckman Coulter DxI 9000 Access Immunoassay Analyzer, Model Number C21510, RSM Pneumatic Tubing Kit item #2, REF C11137; | — |
| 2024-06-14 | US FDA — Medical Devices | Discrete photometric chemistry analyzer for clinical use. | — |
| 2024-04-18 | US FDA — Medical Devices | DxI 9000 Access Immunoassay Analyzer, C11137; in-vitro diagnostic | — |
| 2024-03-05 | US FDA — Medical Devices | DxI 9000 Access Immunoassay Analyzer, REF C11137, vitro diagnostic device used for the quantitative, semi-quantitative, | — |
| 2024-02-07 | US FDA — Medical Devices | Access Substrate, REF 81906, For use with the Access Immunoassay Systems | — |