Normand Remisol Advance Data Manager — Class II medical device recall Z-2332-2021
Terminated recall by Beckman Coulter Inc., reported 2021-09-01, distributed nationwide. There is a potential that the data management system may add additional cells to the patient request which cou
| Recall number | Z-2332-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Beckman Coulter Inc., Brea, CA, United States |
| Recall initiated | 2021-07-15 |
| Classified | 2021-08-23 |
| Reported by FDA | 2021-09-01 |
| Terminated | 2024-06-04 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BE, CA, CH, CN, CZ, FR, GB, IT, NL, NZ, PL, RU, TW |
| Quantity | 180 units |
| Model numbers | C44703, C57017, C69412, C69413 |
Product
Normand Remisol Advance Data Manager, REF: C69412, C69413, C44703, and C57017 is a software device that interfaces between laboratory information systems (LIS) and laboratory instruments.
Reason for recall
There is a potential that the data management system may add additional cells to the patient request which could lead to erroneous patient result.
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-2332-2021. 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.