Device recall
Z-0812-2023: ASTUTE REAGENT ASTUTE ELECTRONIC QUALITY CTRL DEVICE US, CATALOG 400016
FDA device recall · Class II · Biomerieux Inc
Key facts
| Recall number (Z-number) | Z-0812-2023 |
|---|---|
| Recall event | 91148 |
| Product | ASTUTE REAGENT ASTUTE ELECTRONIC QUALITY CTRL DEVICE US, CATALOG 400016 |
| Product code | LON |
| Recalling firm | Biomerieux Inc |
| Recall class | Class II |
| Status | Open, Classified |
| FEI number | 1950204 |
At a glance
- None Linked 510(k)s
- 10–99 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