REMISOL Advance with Software Version 2 — Class II medical device recall Z-2834-2026
Ongoing recall by Beckman Coulter Biomedical GmbH, reported 2026-08-12, distributed in FL, GA, IL, MI, PA. Due to software issues where does not handle combo assay results. The software may replace the final combo tes
| Recall number | Z-2834-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Beckman Coulter Biomedical GmbH, Munchen, Germany |
| Recall initiated | 2026-04-29 |
| Classified | 2026-07-31 |
| Reported by FDA | 2026-08-12 |
| Distributed | FL, GA, IL, MI, PA |
| Countries outside the US | AE, BE, CN, FR, GB, HU, IE, PL, TN, TW |
| Quantity | 20 systems |
| Reason classes | potency, software |
| UPC / GTIN / UDI-DI | 15099590802073 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2834-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.