- Recalling firm
- Beckman Coulter Biomedical GmbH
- Reason for recall
- Due to software issues where does not handle combo assay results. The software may replace the final combo test result with one of the sub-results resulting in incorrect reporting of test outcomes.
- Affected products (lot / model / serial)
- Software Version 2.5 UDI-DI code: 15099590802073
- Units affected
- 20 systems
- Distribution pattern
- U.S.: FL, GA, IL, MI, and PA O.U.S.: Belgium, France, Hungary, Poland, Taiwan (Province of China), Tunisia, United Arab Emirates, and United Kingdom of Great Britain and Northern Ireland.
- Firm location
- Munchen, Germany
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- Letter
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-2834-2026
- Recall initiated
- April 29, 2026
- FDA classification date
- July 31, 2026
- FDA report date
- August 12, 2026
- FDA event ID
- 98927
- Last updated on HTM Vibe
- August 18, 2026