Device recall
Z-2452-2021: Cellex qSARS-Cov-2 Antigen Rapid Test, 25 tests/box, submitted as EUA202955…
FDA device recall · Class II · Cellex
Key facts
| Recall number (Z-number) | Z-2452-2021 |
|---|---|
| Recall event | 88206 |
| Product | Cellex qSARS-Cov-2 Antigen Rapid Test, 25 tests/box, submitted as EUA202955 "declined to issue" |
| Product code | QKP |
| Recalling firm | Cellex |
| Recall class | Class II |
| Status | Open, Classified |
| FEI number | 3014277758 |
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