Device recall
Z-0941-2021: SARS-CoV-2 Antigen Test
FDA device recall · Class II · Qiagen Sciences LLC
Key facts
| Recall number (Z-number) | Z-0941-2021 |
|---|---|
| Recall event | 87205 |
| Product | SARS-CoV-2 Antigen Test |
| Product code | QKP |
| Recalling firm | Qiagen Sciences LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 11, 2022 |
| 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