Beckman Coulter Biomedical Gmbh: Calculator/data Processing Module, For Clinical Use

Recalling firm

Beckman Coulter Biomedical GmbH

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

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.

Classification

Class I

Category

medical device recall

Country

United States

Agency

FDA-DEVICES

Recall date

2026-04-29

Status

Open, Classified

Areas affected

FL, GA, IL, MI, PA

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.

Official recall notice from FDA-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/0cb18c7c-d1dc-4644-9891-f0edc6b83d75