Beckman Coulter DxC 500 AU Clinical Analyzer Modules using software version 1: recall status

Notice names this product. Beckman Coulter’s Beckman Coulter DxC 500 AU Clinical Analyzer Modules using software version 1 is named in FDA Class II recall Z-2974-2026. Your particular item is not yet verified. Compare the identifiers and exclusions in the notice before deciding whether it applies. Agency-reported hazard: a software defect in which the Parameter Package (PP) import logic overwrites all predefined calculated test rules, including those previously modified by the user, upon import of a new Parameter Package version. As a result, usercustomized calculated test rules revert silently to their default expressions, potentially generating erroneous patient test results without an explicit error notification. The issue affects instruments running software version 1.5 or lower and only occurs when a new Parameter Package is imported to a system that already has an existing Parameter Package onboard; new installations are not affected. Identifying details: 1) Part Number C63519, UDI/DI 14987666545058 2) Part Number C63520, UDI/DI 14987666545065. Status: Ongoing.