NucliSENS Lysis Buffer — Class II medical device recall Z-1713-2017
Terminated recall by BioMerieux SA, reported 2017-04-12, distributed in IL, OH, WA. Problem with colored eluates for whole blood extractions
| Recall number | Z-1713-2017 |
|---|---|
| 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 | 2017-03-07 |
| Classified | 2017-04-04 |
| Reported by FDA | 2017-04-12 |
| Terminated | 2020-08-18 |
| Distributed | IL, OH, WA |
| Countries outside the US | AR, AU, BR, CL, ES, FR, GB, HK, IT, NL, PE |
| Quantity | 1,025 |
| Lot numbers | 16092902 |
| Model numbers | 200292 |
Product
NucliSENS Lysis Buffer, REF 200292 NucliSENS Lysis Buffer is intended to be use for the release of total nucleic acid from biological specimens
Reason for recall
Problem with colored eluates for whole blood extractions
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-1713-2017. 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.