FDAFDA recall Z-2834-2026 · Aug 12, 2026
Beckman Coulter Biomedical GmbH: REMISOL Advance with Software Version 2 recall
Recall found
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 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.
What to do
FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.
Recall details
- FDA classification
- Class II: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
- Status
- Ongoing
- Codes, lots and dates
- Software Version 2.5 UDI-DI code: 15099590802073
- Quantity
- 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.
- Recalling firm
- Beckman Coulter Biomedical GmbH, Munchen
- Voluntary or mandated
- Voluntary: Firm initiated
- Recall started
- 2026-04-29
Source: openFDA enforcement record Z-2834-2026 · search recall number Z-2834-2026 in FDA's Enforcement Report.
Copied from the agency record without changes. Data as of Oct 22, 2026, 4:56 AM EDT. The agency notice is the final word.