FDAHealthApril 29, 2026

Beckman Coulter Biomedical GmbH — 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

⚠️ 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.

Is this relevant to me?

Geography: FL, GA, IL, MI, PA
Source agency: FDA
Category: Health
Published: April 29, 2026

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.

What's affected?

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
Brand: Beckman Coulter Biomedical GmbH
Lot code: Software Version 2.5 UDI-DI code: 15099590802073

Additional details

Software Version 2.5 UDI-DI code: 15099590802073

What should I do?

Recommended action

Class II recall. Voluntary: Firm initiated Quantity affected: 20 systems.

View original FDA notice →

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