Notice names this product. Beckman Coulter Biomedical’s REMISOL Advance with Software Version 2 is named in FDA Class II recall Z-2834-2026. Your particular item is not yet verified. Compare the identifiers and exclusions in the notice before deciding whether it applies. Agency-reported 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. Units affected: 20 systems. Status: Ongoing.
This notice names a product; your particular item is not yet verified. Compare every applicable model, serial, lot, production-date or model-year boundary below.
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
Still to verify: match the label on your item with the full official notice, including any exclusions, tables and photos. Some identifiers appear only on the agency website and are absent from this data feed. A missing field does not mean all versions are affected.
If your lot or date falls outside a stated range, this notice has not established that your item is affected. This is not a finding about other recalls or product safety.
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 …
Company / brand: Beckman Coulter Biomedical
Affected product: REMISOL Advance with Software Version 2
Official ID Z-2834-2026 · Official record ↗
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Compiled from connected official public-domain government data. Sources last checked September 7, 2026 at 6:00 AM UTC.