Device recall
Z-2225-2021: MYLA software. Used to manage microbiology test workflow from the reception of…
FDA device recall · Class II · BioMerieux SA
Key facts
| Recall number (Z-number) | Z-2225-2021 |
|---|---|
| Recall event | 87985 |
| Product | MYLA software. Used to manage microbiology test workflow from the reception of requests to the transmission of results by transferring, storing, and displaying medical device data. |
| Recalling firm | BioMerieux SA |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 6, 2023 |
| FEI number | 1000611339 |
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