Beckman Coulter Biomedical GmbH recalls Beckman Coulter DxA Automation System, DxA 5000, REF: B87352
Recalled Product
Beckman Coulter DxA Automation System, DxA 5000, REF: B87352, IVD, 200240V, 16A, 50/60HZ, RxOnly
Hazard / Issue
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
Issued by
FDA
Affected States: AL, CA, FL, IL, IN, KY, MI, MN, MO, NE, NJ, NV, NY, OH, PA, SC, TX, WI, WV
Lot/Code Info: UDI-DI: (01)15099590707118, All DxA serial numbers
View official government recall
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