- Recalling firm
- Beckman Coulter Inc.
- 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.
- Affected products (lot / model / serial)
- 1) Part Number C63519, UDI/DI 14987666545058 2) Part Number C63520, UDI/DI 14987666545065
- Distribution pattern
- Worldwide distribution - US Nationwide.
- Firm location
- Brea, CA, United States
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- Letter
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-2974-2026
- Recall initiated
- July 15, 2026
- FDA classification date
- August 17, 2026
- FDA report date
- August 26, 2026
- FDA event ID
- 99436
- Last updated on HTM Vibe
- September 8, 2026