REMISOL Advance with Software Version 2.5 UDI-DI code recall
Beckman Coulter Biomedical GmbH recalled REMISOL Advance with Software Version 2.5 UDI-DI code on August 12, 2026 because of due to software issues where does not handle combo assay results. It was sold in FL, GA, IL, MI, PA.
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.
What's recalled
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
Quantity: 20 systems
What to do
Check whether you have the product (match the lot numbers, dates or codes in the official notice). Stop using it, and return it or throw it away as the notice says.
Read the official FDA noticeDetails
- Company
- Beckman Coulter Biomedical GmbH, Munchen
- Date
- Severity
- Class II
the product could cause temporary or reversible health problems. - Where sold
- FL, GA, IL, MI, PA
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. - Status
- Ongoing
- Recall number
- Z-2834-2026
- Source
- U.S. Food and Drug Administration
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