Device recall
Z-1401-2015: Vitek 2 AST-P635 REF 416 911 Gram Positive Susceptibility Card, 20 cards per…
FDA device recall · Class III · Biomerieux Inc
Key facts
| Recall number (Z-number) | Z-1401-2015 |
|---|---|
| Recall event | 70645 |
| Product | Vitek 2 AST-P635 REF 416 911 Gram Positive Susceptibility Card, 20 cards per container, IVD. Intended for use with the Vitek 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of Staphylococcus spp., Enterococcus spp., and S. agalactiae. |
| Product code | LTW |
| Recalling firm | Biomerieux Inc |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Mar 22, 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