Device recall
Z-1534-2020: VITEK 2 card AST-N371 - Product Usage: The VITEK 2 is an automated system…
FDA device recall · Class II · bioMerieux, Inc.
Key facts
| Recall number (Z-number) | Z-1534-2020 |
|---|---|
| Recall event | 84993 |
| Product | VITEK 2 card AST-N371 - Product Usage: The VITEK 2 is an automated system consisting of instruments, software, and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast. The VITEK 2 utilizes growth-based biochemical patterns to determine… |
| Recalling firm | bioMerieux, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 28, 2022 |
| FEI number | 3002769706 |
At a glance
- None 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