Reported Aug 12, 2026 · Ongoing · Updated Sep 16, 2026
REMISOL Advance with Software Version 2.5 UDI-DI code: 15099590802073 The Normand Info REMISOL Advance Data Manager…
Beckman Coulter Biomedical GmbH
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Beckman Coulter Biomedical GmbH · Sauerbruchstr. 50 · Munchen
Is this the product you have?
- REMISOL Advance with Software Version 2.5
- UDI-DI code15099590802073 The Normand Info REMISOL Advance Data Manager collects and manages data and workflow for 128 connections
- Lot codes and dates
- Software Version 2.5
- UDI-DI code15099590802073
- Amount recalled
- 20 systems
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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