Beckman Coulter Biomedical GmbH
FDA Regulatory Profile
Summary
- Total Recalls
- 6
- 510(k) Clearances
- 1
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2978-2024 | Class II | Power Express, REF B90918 | July 17, 2024 |
| Z-2980-2024 | Class II | PE Centrifuge Temperature Controlled, REF: B36366, a component of the Power Express. | July 17, 2024 |
| Z-2979-2024 | Class II | PE Centrifuge, REF: B36365, a component of the Power Express | July 17, 2024 |
| Z-2144-2023 | Class II | Beckman Coulter DxA Automation System, DxA 5000, REF: B87352, IVD, 200240V, 16A, 50/60HZ, RxOnly | June 2, 2023 |
| Z-2145-2023 | Class II | Beckman Coulter DxA Automation System, DxA 5000 Fit, REF: B87352, IVD, 200240V, 16A, 50/60HZ, RxOnl | June 2, 2023 |
| Z-2983-2020 | Class II | DxA 5000; Catalog Number:B50516; UDI:15099590707118 - Product Usage: The DxA 5000 is a high-speed, m | June 17, 2020 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K190298 | DxA 5000, DxI 800 Access Immunoassay System, Access Ferritin, Access Folate, Access TSH (3rd IS), Ac | October 4, 2019 |