Drug recall
eMAG System, Ref 418591 It is an In Vitro Diagnostic Medical device intended for the automated isolation…
FDA recall event 77989 · Class II · bioMerieux, Inc.
Key facts
| Event ID | 77989 |
|---|---|
| Recall numbers | Z-3119-2017 |
| Recalling firm | bioMerieux, Inc. |
| Product type | Devices |
| Products | 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… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Some anomalies have been identified during manufacturing controls. |
| Initiation date | Apr 10, 2017 |
| Report date | Sep 20, 2017 |
| Termination date | Feb 24, 2022 |
| City | Durham |
| State | NC |
| Country | United States |
| FEI number | 3002769706 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: