United StatesREMISOL Advance with Software Version 2.5 (UDI‑DI 15099590802073), the REMISOL Advance Data Manager that collects and manages data and workflow for up to 128 connections, is being recalled. The software can fail to handle combo assay results and may replace a final combo test result with one of the sub-results, which can lead to incorrect test reporting.
What's being 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
Recalling firm: Beckman Coulter Biomedical GmbH, Munchen, Germany.
How to identify it
Software Version 2.5 UDI-DI code: 15099590802073
The 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.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
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.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)