Beckman Coulter DxC 500 AU Clinical Analyzer Modules using software version 1.5 or lower: 1) AU w/out ISE, Part Number C63519; 2) AU w/ISE, Part Number C63520; DxC 500 AU Clinical Chemistry Analyzers
Check against the official notice below — it lists the full affected range.
Beckman Coulter Inc. is recalling Beckman Coulter DxC 500 AU Clinical Analyzer Modules with software version 1.5 or lower (Part Numbers C63519 and C63520). The recall involves a software defect in the Parameter Package import logic that overwrites user-customized calculated test rules and reverts them to default expressions without notifying the user. This defect can result in erroneous patient test results. The issue only occurs when a new Parameter Package is imported into a system that already has an existing Parameter Package installed; newly installed systems are not affected.
The recall affects devices distributed worldwide, including throughout the United States. The source document does not specify a remedy or instructions for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
Reason for recall: 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. Distribution: Worldwide distribution - US Nationwide. Lot/code info: 1) Part Number C63519, UDI/DI 14987666545058 2) Part Number C63520, UDI/DI 14987666545065
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.