Recall Z-0680-2022— CELLTRION USA INC
Class I · Terminated
Class I FDA medical device recall by CELLTRION USA INC, initiated 2021-12-02, terminated 2024-06-10. FDA's recall record names no specific 510(k) clearance for this event. Product: Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02. Reason: 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..
- Recalling firm
- CELLTRION USA INC
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2021-12-02
- Terminated
- 2024-06-10
- Firm location
- Jersey City, NJ, United States
Product description
Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.