Reported Jul 26, 2023 · Ongoing
Beckman Coulter DxA Automation System, DxA 5000, REF: B87352, IVD, 200240V, 16A, 50/60HZ, RxOnly
Beckman Coulter Biomedical GmbH
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Beckman Coulter Biomedical GmbH · Sauerbruchstr. 50 · Munchen, N/A · N/A
Is this the product you have?
- Beckman Coulter DxA Automation System, DxA 5000
- REF
B87352IVD200240V16A50/60HZRxOnly
- Lot codes and dates
- UDI-DI(01)15099590707118, All DxA serial numbers
- Amount recalled
- 146 systems
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
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
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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