TemporaryFDAOngoing
Can cause harm that is usually temporary.
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
Check the device or its packaging for
Software Version 2.5 UDI-DI code: 15099590802073
- Why
- 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.
- Distributed
- 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.
- Company
- Beckman Coulter Biomedical GmbH
- Announced
- This is the date the recall was announced. A company may have started it weeks earlier.
- Recall began
Source: FDA record Z-2834-2026 · retrieved 31 July 2026
Read the official notice