Device recall
Z-0176-2011: VITEK 2 Gram Negative Susceptibility Card, AST-GN26, REF 22 244, For In Vitro…
FDA device recall · Class I · Biomerieux Inc
Key facts
| Recall number (Z-number) | Z-0176-2011 |
|---|---|
| Recall event | 56760 |
| Product | VITEK 2 Gram Negative Susceptibility Card, AST-GN26, REF 22 244, For In Vitro Diagnostic Use, 20 cards/box. The firm names on the label are bioMerieux, Inc., Durham, NC, and bioMerieux sa, 69280 Marcy-l'Etoile France. |
| Product code | LON |
| Recalling firm | Biomerieux Inc |
| Recall class | Class I |
| Status | Terminated |
| Termination date | May 8, 2012 |
| 510(k) numbers | K080107 |
| FEI number | 1950204 |
At a glance
- 1–9 Linked 510(k)s
- 100–999 Products in the same recall event
- 100–999 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