FDA recall, , Moderate risk
Normand Info REMISOL Advance Data Manager
REMISOL Advance Data Manager software may replace final combo test results with sub-results, causing incorrect reporting.
Summary by Recall Canary from the FDA notice
What happened
Beckman Coulter Biomedical GmbH, located in Munchen, Germany, is recalling REMISOL Advance with Software Version 2.5, a data manager that collects and manages data and workflow for 128 connections, due to software issues where it 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. The recall affects 20 systems and was initiated on April 29, 2026.
The product was distributed in the U.S. to Florida, Georgia, Illinois, Michigan and Pennsylvania, and O.U.S. to Belgium, France, Hungary, Poland, Taiwan (Province of China), Tunisia, United Arab Emirates, and United Kingdom of Great Britain and Northern Ireland. The FDA added the recall to its Enforcement Report on July 31, 2026.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Affected if its UDI-DI matches.
A UDI-DI is the device identifier printed with the barcode on the device label.
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
- UDI-DI
- 15099590802073
Recall details
- Company began the recall
- Sold in
U.S.: Florida, Georgia, Illinois, Michigan, and Pennsylvania O.U.S.: Belgium, France, Hungary, Poland, Taiwan (Province of China), Tunisia, United Arab Emirates, and United Kingdom of Great Britain and Northern Ireland.
- Company
- Beckman Coulter Biomedical GmbHMunchen, Germany
- Hazard
- Software defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98927
- Recall number
- Z-2834-2026
- Quantity recalled
- 20 systems
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
