Beckman Coulter REMISOL software recalled for incorrect test reporting
Beckman Coulter Biomedical GmbH is recalling REMISOL Advance Data Manager software version 2.5 because it does not handle combo assay results correctly. The software may replace a final combo test result with one of its sub-results, which could lead to incorrect reporting of test outcomes. No injuries have been reported, and the notice covers 20 systems distributed in the U.S. and abroad.
From the FDA notice · Read the official notice ↗ · All Beckman Coulter recalls
What to do
- Check whether your systems run REMISOL Advance software version 2.5 (UDI-DI code 15099590802073).
- Contact Beckman Coulter Biomedical GmbH about affected systems and the software issue.
- The notice doesn't say how to get a fix; contact Beckman Coulter Biomedical GmbH for next steps.
Is yours affected?
Compare your label or packaging with the recalled product.
- 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
- Sold in
- 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.
- Made for
- All ages (under 100 years)
Details
- Units affected
- 20 systems
- Illnesses reported
- None reported
- Manufactured in
- Sauerbruchstr. 50, Munchen, Germany
- Classification
- Class II
- Recall number
- Z-2834-2026
In the FDA's words
- Description
- 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 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. Software Version 2.5 UDI-DI code: 15099590802073 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. Affected quantity: 20 systems
- Hazard
- 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.