NucliSENS easyMAG Magnetic Silica The NucliSENS easyMAG accessory… — Class I medical device recall Z-2342-2016
Terminated recall by BioMerieux SA, reported 2016-08-17, distributed nationwide. Several customer complaints about amplification performance issues when using different batches of MagSil with
| Recall number | Z-2342-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | BioMerieux SA, Marcy L'Etoile, France |
| Recall initiated | 2016-07-08 |
| Classified | 2016-08-09 |
| Reported by FDA | 2016-08-17 |
| Terminated | 2022-03-10 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AT, AU, BR, CH, CN, CO, DE, EE, ES, GB, GR, IL, IN, IT, KR, KW, LV, MX, MY, NL, PL, QA, RU, SE, SG, TH, TR, ZA |
| Quantity | 7,845 units |
| Lot numbers | Z017BA1MS, Z017BB1MS, Z017BD1MS, Z017BE1MS, Z017BF1MS, Z017CA1MS, Z017CC1MS, Z017CD1MS, Z017CE1MS, Z017CF1MS, Z017CG1MS, Z017CH1MS, Z017DA1MS, Z017DB1MS, Z017DC1MS, Z017DD1MS, Z017EA1MS, Z017EB1MS, Z017FB1MS, Z017KF1MS, Z017KG1MS, Z017KH1MS |
Product
NucliSENS easyMAG Magnetic Silica The NucliSENS easyMAG accessory products are reagents and disposable to be used with the bioMerieux extraction systems which mention these products in their User Manuals. They enable the automated extraction (purification and concentration) of total nucleic acids (RNA/DNA) from biological samples which are liquid and homogeneous. These products are intended for in vitro diagnostic use by healthcare professionals only.
Reason for recall
Several customer complaints about amplification performance issues when using different batches of MagSil with the NucliSENS easyMAG extraction platform.
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-2342-2016. 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.