Device recall
Z-1504-2025: Brand Name: QIAstat-Dx Product Name: QIAstat-Dx Respiratory Panel Plus Reference…
FDA device recall · Class II · Qiagen Sciences LLC
Key facts
| Recall number (Z-number) | Z-1504-2025 |
|---|---|
| Recall event | 96521 |
| Product | Brand Name: QIAstat-Dx Product Name: QIAstat-Dx Respiratory Panel Plus Reference Number (REF): 691224 Software Version: n/a Component: n/a |
| Product code | QOF |
| Recalling firm | Qiagen Sciences LLC |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K233100 |
| FEI number | 3003572099 |
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