NucliSENS¿ Magnetic Extraction Reagents — Class II medical device recall Z-0218-2019
Terminated recall by BioMerieux SA, reported 2018-10-31, distributed nationwide. Data loggers showed that one shipment to the United States experienced low temperatures that may impact perfor
| Recall number | Z-0218-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | BioMerieux SA, Marcy L'Etoile, N/A, France |
| Recall initiated | 2018-09-17 |
| Classified | 2018-10-23 |
| Reported by FDA | 2018-10-31 |
| Terminated | 2020-05-18 |
| Distributed | Nationwide (US) |
| Quantity | 42 units |
| Lot numbers | 17121501 |
| Expiration dates | 2018-11-28 |
Product
NucliSENS¿ Magnetic Extraction Reagents
Reason for recall
Data loggers showed that one shipment to the United States experienced low temperatures that may impact performance of this product.
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-0218-2019. 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.