Company: Beckman Coulter Biomedical GmbH
Date of Enforcement Report: 7/31/2026
Class: II

PRODUCT

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.

Recall Number:

Z-2834-2026

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.

RECALLING FIRM/MANUFACTURER:

Beckman Coulter Biomedical GmbH

VOLUME:

20 systems

DISTRIBUTION:

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.