Device recall
Z-1639-2016: Vitek 2 Gram Positive Susceptibility Test Cards (AST-P636 REF 417951), 20…
FDA device recall · Class I · Biomerieux Inc
Key facts
| Recall number (Z-number) | Z-1639-2016 |
|---|---|
| Recall event | 73413 |
| Product | Vitek 2 Gram Positive Susceptibility Test Cards (AST-P636 REF 417951), 20 cards/kit. Product Usage: The VITEK 2 Gram Positive Susceptibility Card is intended for use with VITEK 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of Staphylococcus spp., Enterococcus… |
| Product code | LTW |
| Recalling firm | Biomerieux Inc |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Mar 8, 2018 |
| 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