Recall Z-0680-2022 ยท QKP Coronavirus Antigen Detection Test System.
CELLTRION USA INC
Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02
| Date | Mar 2, 2022 (initiated Dec 2, 2021) |
| Status | Terminated |
| Reason | Returned test kits were erroneously shipped to customers. The kits are intended for Research Use Only (RUO). Additional RUO test kits were shipped to customers unlikely to use them for RUO purposes, and the firm provided a letter assuring distributors that RUO tests could be used for clinical diagnosis. |
| Root cause | Employee error |
| Action | On December 2, 2021, the firm notified the affected distributor that the two lots are Research Use Only and should not be used. The distributor then notified the customer. Customer reported all product had been used. |
| Quantity | 8080 kits originally distributed; 726 kits redistributed |
| Distribution | Distributed to TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.