Device recall
Z-2938-2020: QIAstat-Dx Respiratory SARS-CoV-2 Panel REF 691223 (US IVD under FDA EUA)…
FDA device recall · Class II · Qiagen Sciences LLC
Key facts
| Recall number (Z-number) | Z-2938-2020 |
|---|---|
| Recall event | 86149 |
| Product | QIAstat-Dx Respiratory SARS-CoV-2 Panel REF 691223 (US IVD under FDA EUA) - Product Usage: intended for the qualitative detection and differentiation of nucleic acid from multiple respiratory viral and bacterial organisms, including the SARS-CoV-2 virus, in nasopharyngeal swabs (NPS) eluted in… |
| Product code | QLT |
| Recalling firm | Qiagen Sciences LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 22, 2021 |
| FEI number | 3003572099 |
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