Device recall
Z-0953-2022: Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02
FDA device recall · Class I · CELLTRION USA INC
Key facts
| Recall number (Z-number) | Z-0953-2022 |
|---|---|
| Recall event | 89965 |
| Product | Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02 |
| Product code | QKP |
| Recalling firm | CELLTRION USA INC |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Jun 11, 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