Device recall
Z-2215-2023: QIAstat-Dx Respiratory SARS-CoV-2 Panel -IVD intended for the detection and…
FDA device recall · Class II · Qiagen GmbH
Key facts
| Recall number (Z-number) | Z-2215-2023 |
|---|---|
| Recall event | 92540 |
| Product | QIAstat-Dx Respiratory SARS-CoV-2 Panel -IVD intended for the detection and differentiation of nucleic acid from SARS-CoV-2 and the following organism types and subtypes: Adenovirus, Coronavirus 229E, Coronavirus HKU1, Coronavirus NL63, Coronavirus OC43, SARS-CoV-2, Human Metapneumovirus A+B… |
| Product code | QJR |
| 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