REMISOL Advance with Software Version 2.5 UDI-DI code: 15099590802073 The Normand... recall (Beckman Coulter Biomedical GmbH)

Medical deviceClass IIOngoing

Summary: Beckman Coulter Biomedical GmbH is recalling 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. Reason: 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 is 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

Why

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.

How serious is it

Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.

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. (states named: Florida, Georgia, Illinois, Michigan, Pennsylvania)

How to tell if yours is affected

Software Version 2.5 UDI-DI code: 15099590802073

What to do

Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.

Recall facts

More recalls from Beckman Coulter Biomedical GmbH · all medical device recalls · recalls from April 2026

Official FDA record