Recall found. Beckman Coulter Biomedical is named in FDA Class II recall Z-2834-2026 covering REMISOL Advance with Software Version 2. Hazard: 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. Identifying details: Software Version 2.5 UDI-DI code: 15099590802073. Status: Ongoing.
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 …
Official ID Z-2834-2026 · Official record ↗
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Compiled from official public-domain government data. Last checked September 7, 2026 at 6:00 AM UTC.