Device recall
Z-3179-2018: VITEK(R) 2 AST-P640, For susceptibility testing of Staphylococcus spp…
FDA device recall · Class II · bioMerieux, Inc.
Key facts
| Recall number (Z-number) | Z-3179-2018 |
|---|---|
| Recall event | 80860 |
| Product | VITEK(R) 2 AST-P640, For susceptibility testing of Staphylococcus spp. Enterococcus spp., ad S agalactiae against specified antimicrobials, REF 418579 Product Usage: VITEK 2 is an automated system consisting of instruments, software and reagent cards designed for the identification and antimicrobial… |
| Product code | LCD |
| Recalling firm | bioMerieux, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 2, 2020 |
| FEI number | 3002769706 |
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