Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02
FDA device recall Z-0680-2022 · posted 2022-03-02 · Terminated
Recall details
- Recalling firm
- CELLTRION USA INC
- 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.
- 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.
- Root cause
- Employee error
- Status
- Terminated
- Product code
- QKP
- Quantity affected
- 8080 kits originally distributed; 726 kits redistributed
- Distribution
- Distributed to TX.
- Date initiated
- 2021-12-02
- Date posted
- 2022-03-02
- Date terminated
- 2024-06-10
- Location
- Jersey City, NJ
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