Drug recall
Beckman Coulter DxA Automation System, DxA 5000 Fit, REF: B87352, IVD, 200240V, 16A, 50/60HZ, RxOnly
FDA recall event 92484 · Class II · Beckman Coulter Biomedical GmbH
Key facts
| Event ID | 92484 |
|---|---|
| Recall numbers | Z-2144-2023, Z-2145-2023 |
| Recalling firm | Beckman Coulter Biomedical GmbH |
| Product type | Devices |
| Products | Beckman Coulter DxA Automation System, DxA 5000 Fit, REF: B87352, IVD, 200240V, 16A, 50/60HZ, RxOnly, Beckman Coulter DxA Automation System, DxA 5000, REF: B87352, IVD, 200240V, 16A, 50/60HZ, RxOnly |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | A software defect in the DxA Automation System may cause tests to be run on patient samples in tube types not compatible with the requested test, leading to erroneous patient results |
| Initiation date | Jun 2, 2023 |
| Report date | Jul 26, 2023 |
| City | Munchen |
| Country | Germany |
| FEI number | 3006677029 |
At a glance
- 1–9 Products in this recall
- None FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: