FDAFDA · Food and drugs·Recall number Z-2834-2026
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
Published August 12, 2026 · Recall initiated: April 29, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's 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
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Beckman Coulter Biomedical GmbH
- Distributor
- 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.
- Lot
- Software Version 2.5 UDI-DI code: 15099590802073
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Germany
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.