Z-2834-2026 Class II Ongoing
FDA device recall Z-2834-2026 was initiated by Beckman Coulter Biomedical GmbH on April 29, 2026 and is designated Class II. Reason for recall: 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. The recall status is ongoing. Affected quantity: 20 systems.
Recall Details
- Product Type
- Devices
- Report Date
- August 12, 2026
- Initiation Date
- April 29, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 20 systems
Product Description
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 for Recall
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.
Distribution Pattern
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.
Code Information
Software Version 2.5 UDI-DI code: 15099590802073