Device recall
Z-0522-2025: Kreatech PapV-16, Flu labeled ISH probe, to detect presence of HPV-16 DNA…
FDA device recall · Class II · Kreatech Biotechnology Bv
Key facts
| Recall number (Z-number) | Z-0522-2025 |
|---|---|
| Recall event | 95668 |
| Product | Kreatech PapV-16, Flu labeled ISH probe, to detect presence of HPV-16 DNA inserts in human tissue, Model Number 40V016V495 |
| Product code | MVU |
| Recalling firm | Kreatech Biotechnology Bv |
| Recall class | Class II |
| Status | Open, Classified |
| FEI number | 3003137205 |
At a glance
- None 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