FDA Device recall Z-3119-2017
eMAG System, Ref 418591 It is an In Vitro Diagnostic Medical device intended for the automated isolation (purification and concentration) o…
- FDA Device
- Class II
- terminated
- Published 2017-09-20
On 2017-09-20 the FDA classified a Class II recall of eMAG System, Ref 418591 It is an In Vitro Diagnostic Medical device intended for the automated isolation (purification and concentration) o… by Biomerieux, citing some anomalies have been identified during manufacturing controls.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-3119-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-04-10 |
| Published | 2017-09-20 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Biomerieux |
| Distribution | US |
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
Some anomalies have been identified during manufacturing controls.
Identifiers
| code_info | Serial Numbers - IM03001, IM03002, IM3004, IM03005, IM03006, IM03007, IM03008, IM03009, IM03011, IM03012, IM03013, IM03014, IM03015, IM03017, IM03019 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3119-2017%22
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