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July 14, 2023
14
Jul

FDA Recall: Software Defect May Lead to Erroneous Results

July 14, 2023
Company: Beckman Coulter Biomedical GmbH Date of Enforcement Report: 07/14/2023 Class II PRODUCT Beckman Coulter DxA Automation System, DxA 5000, REF: B87352, IVD, 200240V, 16A, 50/60HZ, RxOnly Recall Number: Z-2144-2023 REASON: A software defect in the DxA Automation System may cause tests to be run on patient samples in tube types not compatible with the...
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