Device recall
Z-1908-2013: bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2…
FDA device recall · Class II · Biomerieux Inc
Key facts
| Recall number (Z-number) | Z-1908-2013 |
|---|---|
| Recall event | 65470 |
| Product | bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, UPDT V2S 6.01ML1. Part number: 414537. The product is used with the VITEK 2 automated system which consists of instruments, software and reagent cards designed for the identification and… |
| Product code | LTW |
| Recalling firm | Biomerieux Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 1, 2015 |
| FEI number | 1950204 |
At a glance
- None Linked 510(k)s
- 10–99 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