Normand Remisol Advance Data Manager is a software device that… — Class II medical device recall Z-1831-2021
Terminated recall by Normand-Info S.A.S.U., reported 2021-06-16, distributed nationwide. Instructions For Use for software versions 1.5 to 1.9 did not provide sufficient instructions regarding the pr
| Recall number | Z-1831-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Normand-Info S.A.S.U., Arras CEDEX, N/A, France |
| Recall initiated | 2021-03-22 |
| Classified | 2021-06-08 |
| Reported by FDA | 2021-06-16 |
| Terminated | 2022-12-30 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, BE, CA, CH, CN, CO, CZ, DE, DK, ES, FR, GB, GR, HK, IE, IL, IN, IT, LT, MA, MY, NL, NO, NZ, PL, PT, QA, RU, SA, SE, SG, SI, SK, TH, TN, TR, TW, ZA |
| Quantity | 8,402 units |
| Reason classes | software |
| Model numbers | B08688 |
Product
Normand Remisol Advance Data Manager is a software device that interfaces between laboratory information systems (LIS) and laboratory instruments.
Reason for recall
Instructions For Use for software versions 1.5 to 1.9 did not provide sufficient instructions regarding the proper programming and testing of rules. Therefore, rules written by users that were not validated or incorrectly validated 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-1831-2021. 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.