Device recall
Z-1592-2024: Actim PROM dipstik, REF 30831ETUS; qualitative immunoassay rapid test for…
FDA device recall · Class II · ACTIM OY
Key facts
| Recall number (Z-number) | Z-1592-2024 |
|---|---|
| Recall event | 93845 |
| Product | Actim PROM dipstik, REF 30831ETUS; qualitative immunoassay rapid test for rupture of fetal membrane |
| Product code | OAM |
| Recalling firm | ACTIM OY |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K123986 |
| FEI number | 1000212994 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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