Device recall
Z-3076-2017: VITEK 2 Compact 30, REF numbers: 27530 and 27530R (clinical), and 27630 and…
FDA device recall · Class II · Biomerieux Inc
Key facts
| Recall number (Z-number) | Z-3076-2017 |
|---|---|
| Recall event | 77799 |
| Product | VITEK 2 Compact 30, REF numbers: 27530 and 27530R (clinical), and 27630 and 17630R (industry) software and reagent cards designed for the identification (ID) and antimicrobial susceptibility testing (AST) of bacteria and yeast. |
| Product code | LON |
| Recalling firm | Biomerieux Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 16, 2020 |
| 510(k) numbers | K050002 |
| 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