Device recall
Z-1603-2015: Vitek 2 AST-YS01 REF 22 108, Fungal Susceptibility Card, 20 cards per carton…
FDA device recall · Class II · Biomerieux Inc
Key facts
| Recall number (Z-number) | Z-1603-2015 |
|---|---|
| Recall event | 70868 |
| Product | Vitek 2 AST-YS01 REF 22 108, Fungal Susceptibility Card, 20 cards per carton, IVD. Intended for use with the Vitek 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of clinically significant yeasts to antifungal agents when used as instructed. |
| Product code | LTW |
| Recalling firm | Biomerieux Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 24, 2017 |
| FEI number | 1950204 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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