Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02
- Company
- Celltrion Usa Inc
- Recall Initiated
- December 2, 2021
- Posted
- March 2, 2022
- Terminated
- June 10, 2024
- Recall Number
- Z-0680-2022
- Quantity
- 8080 kits originally distributed; 726 kits redistributed
- Firm Location
- Jersey City, NJ
Reason for Recall
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.
Distribution
Distributed to TX.
Lot / Code Info
Lots COVGCCF0001, COVGCCF0002
Root Cause
Employee error
Action Taken
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.