Recall Z-0953-2022 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 | Apr 27, 2022 (initiated Apr 1, 2022) |
| Status | Terminated |
| Reason | Point of Care (PoC) rapid test products were distributed to customers who did not have a valid CLIA ID. |
| Root cause | Other |
| Action | On April 1, 2022, the firm notified distributors of the issue via letter, following up with meetings with each distributor on April 5, 2022 and emails on April 6, 2022. The firm instructed distributors to communicate the recall to their affected customers, down to the user level. Customers who do not have CLIA IDs must return the product to their distributors. |
| Quantity | 12,632 kits |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.