Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02
- Company
- Celltrion Usa Inc
- Recall Initiated
- December 28, 2021
- Posted
- March 2, 2022
- Terminated
- June 10, 2024
- Recall Number
- Z-0659-2022
- Quantity
- 243 kits (6,075 tests)
- Firm Location
- Jersey City, NJ
Reason for Recall
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.
Distribution
US distribution to CA, FL, NJ, NY, PA, SC.
Lot / Code Info
Lot COVGCCM0008
Root Cause
Process control
Action Taken
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.