Recall Z-0659-2022 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 28, 2021) |
| Status | Terminated |
| Reason | The affected lot was placed under quarantine in September 2021 due to complaints of alleged false positives, but 243 kits were erroneously released to customers in December 2021. |
| Root cause | Process control |
| Action | The firm initially placed a hold on product due to complaints of false positive and false negative results in September 2021. After product was erroneously distributed from this lot in December 2021, the firm notified affected customers that the lot should not have been distributed and should not be used. This email went out on or around December 28, 2021. Customers were instructed to NOT use the affected lot. |
| Quantity | 243 kits (6,075 tests) |
| Distribution | US distribution to CA, FL, NJ, NY, PA, SC. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.