Device recall
Z-2336-2025: Estrone RIA Catalog Number DSL8700 UDI Code: 15099590211615 Estrone RIA is an in…
FDA device recall · Class II · Immunotech A.S.
Key facts
| Recall number (Z-number) | Z-2336-2025 |
|---|---|
| Recall event | 97090 |
| Product | Estrone RIA Catalog Number DSL8700 UDI Code: 15099590211615 Estrone RIA is an in vitro diagnostic manual medical device used by healthcare professionals for the quantitative measurement of estrone in human serum and plasma. |
| Product code | CGF |
| Recalling firm | Immunotech A.S. |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K935013 |
| FEI number | 3003385757 |
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