Recall database

Beckman Coulter Biomedical GmbH recalls

Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.

Showing 1–1 of 1 recalls

Class IIOngoingZ-2834-2026

Beckman Coulter Biomedical GmbH recalls REMISOL Advance with Software Version 2.5 UDI-DI code: 15099590802073 The Normand I…

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.

For Clinical Use Calculator/Data Processing Module
Under Investigation by firm

Beckman Coulter Biomed…Aug 12, 2026