Device recall
Z-1307-2021: VITEK 2 (version numbers 8.01, 8.02 (8.0x) and 9.01, 9.02 (9.0x) with the…
FDA device recall · Class II · Biomerieux Inc
Key facts
| Recall number (Z-number) | Z-1307-2021 |
|---|---|
| Recall event | 87249 |
| Product | VITEK 2 (version numbers 8.01, 8.02 (8.0x) and 9.01, 9.02 (9.0x) with the external communication configured to HL7 (system, test, automated, antimicrobial susceptibility, short incubation). VITEK 2 is an automated system consisting of instruments, software and reagent cards designed for the… |
| Product code | LON |
| Recalling firm | Biomerieux Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 12, 2023 |
| 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