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Beckman Coulter Biomedical GmbH: REMISOL Advance with Software Version 2.5 UDI-DI code: 15099590802073 The Normand Info REMISOL Advance Data Manager collects and manages

Medical DevicesSource: FDA (device) · Date: 2026-08-12

Read the official notice at FDA (device) →

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
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 / 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.
Classification
Class II
Status
Ongoing
Distribution / 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.
Recall initiated
2026-04-29
Code info
Software Version 2.5 UDI-DI code: 15099590802073
Product quantity
20 systems
Voluntary mandated
Voluntary: Firm initiated
City
Munchen
Country
Germany
Event id
98927
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