NucliSENS magnetic extraction reagents — Class I medical device recall Z-0977-2017
Terminated recall by BioMerieux SA, reported 2017-01-25, distributed nationwide. A drift of the performance with the BK test (BK virus, worst case application) was observed for some silica ba
| Recall number | Z-0977-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | BioMerieux SA, Marcy L'Etoile, France |
| Recall initiated | 2016-11-23 |
| Classified | 2017-01-13 |
| Reported by FDA | 2017-01-25 |
| Terminated | 2022-03-10 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AT, AU, BR, CA, CH, CL, CN, CO, CZ, DE, ES, FR, GB, GR, HU, IL, IN, IQ, IT, JP, KE, KR, LV, MA, MY, NL, PE, PL, PT, RO, RS, RU, SE, SG, TH, TR, UY, ZA |
| Quantity | 3,723 units |
| Lot numbers | 16072701 |
Product
NucliSENS magnetic extraction reagents, For in vitro diagnostic use, Product Usage: NucliSENS miniMAG¿ is intended to be used for the extraction of total nucleic acids from biological specimens.
Reason for recall
A drift of the performance with the BK test (BK virus, worst case application) was observed for some silica batches of Magnetic Silica (MagSil). This is the same issue as in recall Z-2342-2016.
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-0977-2017. 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.