Device recall
Z-0022-2025: FastPack TSH Calibrator Kit, REF: 25000024, For use in conjunction with the…
FDA device recall · Class II · Qualigen Inc
Key facts
| Recall number (Z-number) | Z-0022-2025 |
|---|---|
| Recall event | 95326 |
| Product | FastPack TSH Calibrator Kit, REF: 25000024, For use in conjunction with the FastPack IP TSH Immunoassay and FastPack IP System Analyzer |
| Product code | JLW |
| Recalling firm | Qualigen Inc |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K052301 |
| 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