Recall Z-0731-2022 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 8, 2022 (initiated Feb 25, 2022) |
| Status | Open, Classified |
| Reason | Kits were labeled with incorrect expiration dates. |
| Root cause | Incorrect or no expiration date |
| Action | An URGENT: MEDICAL DEVICE RECALL notification letter dated 2/25/22 was sent to customers. Immediate Actions to be taken by You: 1. Examine your inventory for affected product. Please identify the LOT number printed on the outer box to determine whether the products you received are from lots COVGCCM0006, COVGCCM0007, COVGCCM0008, COVGCCM1002, COVGCCM1003, COVGCCM1004, COVGCCM1005, COVGCCM1006 or COVGCCM1007. 2. If you identify kits from the lots above in your inventory, quarantine the products and do not use them. 3. If you identified kits with Lot Number COVGCCM0006, COVGCCM0007, COVGCCM0008 |
| Quantity | 1,228,200 tests |
| Distribution | The products were distributed to the following US states: CA, CT, FL, HI, MA, MT, NJ, NY, PA, TN, and TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.