medical Class II Updated 2023-07-26

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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