Beckman Coulter Biomedical GmbH recalls REMISOL Advance with Software Version 2.5
- Recalling company
- Beckman Coulter Biomedical GmbH
- Product
- REMISOL Advance with Software Version 2.5 UDI-DI code: 15099590802073 The Normand Info REMISOL Advance Data Manager collects and manages data and workflow for 128 connections
- Reason
- 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.
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Apr 29, 2026
- Reported
- Aug 12, 2026
- Distribution
- 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.
- Status
- Ongoing
- Quantity
- 20 systems
- Lot / codes
- Software Version 2.5 UDI-DI code: 15099590802073
- Company location
- Munchen
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-2834-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-2834-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.