Remisol Advance running Software Version 1 — Class II medical device recall Z-2743-2020
Terminated recall by Normand-Info S.A.S.U., reported 2020-08-12, distributed nationwide. Results from repeated run for WBC (White Bloodcell Count), UWBC (Urine Whit Bloodcell Count) and PLT (Platelet
| Recall number | Z-2743-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Normand-Info S.A.S.U., Arras CEDEX, France |
| Recall initiated | 2020-04-30 |
| Classified | 2020-07-31 |
| Reported by FDA | 2020-08-12 |
| Terminated | 2022-02-10 |
| Distributed | Nationwide (US) |
| Countries outside the US | BE, BH, CA, CH, CN, CZ, DE, FR, GB, HK, IL, MY, NL, TR, TW |
| Quantity | 663 |
Product
Remisol Advance running Software Version 1.12 The Normand Info Remisol Advance Data Manager collects and manages data and workflow for 128 connections (Beckman Coulter Instruments, automations, LIS &). It can also be connected to a host system.
Reason for recall
Results from repeated run for WBC (White Bloodcell Count), UWBC (Urine Whit Bloodcell Count) and PLT (Platelets) are deleted in RADV. Use may lead to erroneous 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-2743-2020. 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.