Device recall
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
- Recall number
- Z-2973-2026
- Event id
- 99436
- Status
- Ongoing
- FDA classification
- Class II
- Recalling firm
- Beckman Coulter Inc.
- Report date
- Aug 26, 2026
- Posted
- Aug 17, 2026
- Initiated
- Jul 15, 2026
- Center classification date
- Aug 17, 2026
- Product code
- JJE
- Device type
- Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
- Reason
- 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.
- Root cause
- Software design (manufacturing process)
- Code info
- 1) Part Number C63522, UDI/DI 14987666545089; 2) Part Number C63521, UDI/DI 14987666545072; 3) Part Number C13252, UDI/DI 15099590742331.
- Distribution
- Worldwide distribution - US Nationwide.
- Voluntary or mandated
- Voluntary: Firm initiated
- Related 510(k)s
- K242190
- Location
- Brea, CA, United States