Device recall
Z-2049-2011: VITEK 2 Gram Negative Susceptibility Card, AST-N183, REF 411 021, For In Vitro…
FDA device recall · Class I · Biomerieux Inc
Key facts
| Recall number (Z-number) | Z-2049-2011 |
|---|---|
| Recall event | 58135 |
| Product | VITEK 2 Gram Negative Susceptibility Card, AST-N183, REF 411 021, For In Vitro Diagnostic Use, 20 cards/box. The firm names on the label are bioMerieux, Inc., Durham, NC, and bioMerieux sa, Marcy-l'Etoile France. The cards are intended for use with the Vitek 2 systems in clinical laboratories as an… |
| Product code | LON |
| Recalling firm | Biomerieux Inc |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Jun 1, 2012 |
| 510(k) numbers | K080107 |
| FEI number | 1950204 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 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