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Beckman Coulter Biomedical GmbH recalls REMISOL Advance with Software Version 2.5 UDI-DI code: 15099590802073 The Normand Info REMISOL Advance Data Manager
Recalled August 12, 2026 · FDA recall Z-2834-2026 · Beckman Coulter Biomedical
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. · FDA Class II
Units
20 systems
Sold at
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.
Description
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.
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
Manufacturer(s)
Beckman Coulter Biomedical GmbH
Made in
Germany
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →