Device recall
Z-2245-2023: QIAstat-Dx Respiratory SARS-CoV-2 Panel -US IVD qualitative test intended for…
FDA device recall · Class II · Qiagen GmbH
Key facts
| Recall number (Z-number) | Z-2245-2023 |
|---|---|
| Recall event | 92609 |
| Product | QIAstat-Dx Respiratory SARS-CoV-2 Panel -US IVD qualitative test intended for analyzing nasopharyngeal swab (NPS) samples from patients suspected of respiratory infection for the presence of viral or bacterial nucleic acids REF 691223 |
| Product code | QLT |
| Recalling firm | Qiagen GmbH |
| Recall class | Class II |
| Status | Open, Classified |
| FEI number | 3004013603 |
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