Device recall
Z-1201-2023: MYLA comprises AST Filters in conjunction with VITEK MS; middleware which…
FDA device recall · Class II · Biomerieux Inc
Key facts
| Recall number (Z-number) | Z-1201-2023 |
|---|---|
| Recall event | 91617 |
| Product | MYLA comprises AST Filters in conjunction with VITEK MS; middleware which connects microbiology laboratory instruments for ID/AST and blood culture activities and the laboratory information system (LIS). |
| Product code | OUG |
| Recalling firm | Biomerieux Inc |
| Recall class | Class II |
| Status | Open, Classified |
| FEI number | 1950204 |
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