Device recall
Z-1742-2020: The VITEK 2 Gram-positive Susceptibility Card is intended for use with the VITEK…
FDA device recall · Class II · Biomerieux Inc
Key facts
| Recall number (Z-number) | Z-1742-2020 |
|---|---|
| Recall event | 85209 |
| Product | The VITEK 2 Gram-positive Susceptibility Card is intended for use with the VITEK 2 Systems in clinical laboratories as an in-vitro test to determine susceptibility of Staphylococcus spp., Enterococcus spp., and S. agalactiae to antimicrobial agents when used as instructed. |
| Recalling firm | Biomerieux Inc |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K053097 |
| 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