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Beckman Coulter Biomedical GmbH FDA Recalls
6 recalls on file across devices, 0 of them Class I and 6 still open. This firm is not matched to a listed company.
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Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| REMISOL Advance with Software Version 2.5 UDI-DI code: 15099590802073 The Normand Info REMISOL Advance Data Manager Class IIApr 29, 2026Due to software issues where does not handle combo assay res |
| PE Centrifuge Temperature Controlled, REF: B36366, a component of the Power Express.Class IIJul 17, 2024The adhesive joint between the plastic socket and metal comp |
| PE Centrifuge, REF: B36365, a component of the Power ExpressClass IIJul 17, 2024The adhesive joint between the plastic socket and metal comp |
| Power Express, REF B90918Class IIJul 17, 2024The adhesive joint between the plastic socket and metal comp |
| Beckman Coulter DxA Automation System, DxA 5000, REF: B87352, IVD, 200240V, 16A, 50/60HZ, RxOnlyClass IIJun 2, 2023A software defect in the DxA Automation System may cause tes |
| Beckman Coulter DxA Automation System, DxA 5000 Fit, REF: B87352, IVD, 200240V, 16A, 50/60HZ, RxOnlyClass IIJun 2, 2023A software defect in the DxA Automation System may cause tes |