Device recall
Z-0805-2025: The FastPack IP Sex Hormone Binding Globulin Immunoassay, Part #25000081, is for…
FDA device recall · Class III · Qualigen Inc
Key facts
| Recall number (Z-number) | Z-0805-2025 |
|---|---|
| Recall event | 95807 |
| Product | The FastPack IP Sex Hormone Binding Globulin Immunoassay, Part #25000081, is for the quantitative measurement of SHBG in human serum and plasma. For in vitro diagnostic Use and contains 30 FastPacks. |
| Product code | CDZ |
| Recalling firm | Qualigen Inc |
| Recall class | Class III |
| Status | Open, Classified |
| 510(k) numbers | K182521 |
| FEI number | 3003355251 |
At a glance
- 1–9 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