Device recall
Z-0558-2022: Celltrion DiaTrust COVID-19 Ag Rapid Test, REF CT-P60 D-2 01. Contains 25…
FDA device recall · Class II · CELLTRION USA INC
Key facts
| Recall number (Z-number) | Z-0558-2022 |
|---|---|
| Recall event | 89455 |
| Product | Celltrion DiaTrust COVID-19 Ag Rapid Test, REF CT-P60 D-2 01. Contains 25 disposable test tubes with extraction buffer, 25 filter caps, 25 sterilized swabs per box. |
| Product code | QKP |
| Recalling firm | CELLTRION USA INC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 17, 2024 |
| FEI number | 3015423092 |
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