Beckman Coulter DxC 500i Clinical Analyzer Modules using software version 1.5 or lower: 1) DxC 500 AU Module w/ISE, DxC 500i, Part Number C63522; 2) DxC 500 AU Module, DxC 500i, Part Number C63521; 3) Access 2 Module, DxC 500i, Part Number C13252; DxC 500 AU Clinical Chemistry Analyzers
Check against the official notice below — it lists the full affected range.
Beckman Coulter Inc. has recalled Beckman Coulter DxC 500i Clinical Analyzer Modules running software version 1.5 or lower due to a software defect in the Parameter Package import logic. When a new Parameter Package version is imported into a system that already has an existing Parameter Package, the defect overwrites all predefined calculated test rules, including any previously customized by the user. This causes user-customized rules to revert silently to their default expressions without providing an explicit error notification, which could result in erroneous patient test results. The defect does not affect new installations, only systems receiving Parameter Package updates.
The affected products include the DxC 500 AU Module with ISE (Part Number C63522), the DxC 500 AU Module (Part Number C63521), and another module (Part Number C13252), which have been distributed worldwide and throughout the US. The source document does not specify a remedy or recommended action 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 C63522, UDI/DI 14987666545089; 2) Part Number C63521, UDI/DI 14987666545072; 3) Part Number C13252, UDI/DI 15099590742331.
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.