eMAG System — Class II medical device recall Z-3119-2017
Terminated recall by bioMerieux, Inc., reported 2017-09-20, distributed nationwide. Some anomalies have been identified during manufacturing controls.
| Recall number | Z-3119-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | bioMerieux, Inc., Durham, NC, United States |
| Recall initiated | 2017-04-10 |
| Classified | 2017-09-12 |
| Reported by FDA | 2017-09-20 |
| Terminated | 2022-02-24 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, CH, DE, ES, FR, GB, HK, IT, NL, SE, TH |
| Quantity | 15 us |
| Serial numbers | IM03001, IM03002, IM03005, IM03006, IM03007, IM03008, IM03009, IM03011, IM03012, IM03013, IM03014, IM03015, IM03017, IM03019, IM3004 |
| Model numbers | 418591 |
Product
eMAG System, Ref 418591 It is an In Vitro Diagnostic Medical device intended for the automated isolation (purification and concentration) of total nucleic acids (RNA/DNA) from biological specimens, with liquid and homogeneous properties (as part of their natural characteristics or after pre-treatment).
Reason for recall
Some anomalies have been identified during manufacturing controls.
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-3119-2017. 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.