Device recall
Z-2331-2018: VIDAS FSH, Ref 30407-01, IVD, Rx. The firm name on the label is bioMerieux SA…
FDA device recall · Class II · BioMerieux SA
Key facts
| Recall number (Z-number) | Z-2331-2018 |
|---|---|
| Recall event | 79620 |
| Product | VIDAS FSH, Ref 30407-01, IVD, Rx. The firm name on the label is bioMerieux SA, France. For use on the instruments of the VIDAS family (VITEK ImmunoDiagnostic Assay System) as an automated quantitative enzyme-linked fluorescent immunoassay (ELFA) for the determination of human follicle stimulating… |
| Product code | CGJ |
| Recalling firm | BioMerieux SA |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 2, 2025 |
| 510(k) numbers | K921746 |
| FEI number | 1000611339 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database