Remisol Advance Software — Class II medical device recall Z-0235-2018
Terminated recall by Normand Informatique, reported 2017-12-20. Beckman Coulter has identified that due to a software nonconformity in connection with a changed service setti
| Recall number | Z-0235-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Normand Informatique, Arras CEDEX, N/A, France |
| Recall initiated | 2017-10-16 |
| Classified | 2017-12-13 |
| Reported by FDA | 2017-12-20 |
| Terminated | 2024-02-13 |
| Countries outside the US | AU, DE, FR, IL, RU |
| Quantity | 34 units |
| Reason classes | software |
| Model numbers | B32129 |
Product
Remisol Advance Software (Driver Architect) Catalog Number B32129 The Remisol Advance Data Manager (Stand alone Data Management Systems) collects and manages data and manages workflows for connected systems. (i.e. Beckman Coulter Instruments, Automations, LIS &). It provides data analysis capabilities such as automatic results validation, delta checking, reflex testing, quality control, results editing and data management (i.e. archiving and restoration of patient results). The Remisol Advance system also offers workstation consolidation to three Beckman Coulter instruments from a single user console.
Reason for recall
Beckman Coulter has identified that due to a software nonconformity in connection with a changed service setting Remisol could display wrong results.
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-0235-2018. 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.