Recall Z-0558-2022
Celltrion USA Inc · initiated December 1, 2021
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Celltrion DiaTrust COVID-19 Ag Rapid Test, REF CT-P60 D-2 01. Contains 25 disposable test tubes with extraction buffer, 25 filter caps, 25 sterilized swabs per box.
Codes / lots: All lots
Reason for recall
The European version of the DiaTrust COVID-19 Ag Rapid Test is not approved for marketing in the U.S. but was illegally distributed in the U.S. The packaging and labeling of the European test kit is different from the US test kit and is NOT authorized for distribution in the US.
FDA-determined cause: No Marketing Application
Action taken
Celltrion Healthcare informs Celltrion USA on 2021-11-11 that it had sent cease and desist letter to distributors who were illegally distributing non-EUA product in the U.S. Celltrion demanded return of all EU product from distributors' inventory and demanded removal of all EU DiaTrustTests from the U.S. In addition, the firm sent letters to all EU distributors warning against diversion and obtaining confirmation that distributors understand limitations on distribution only within the EU.
Details
- Recall number
- Z-0558-2022
- Initiated
- December 1, 2021
- Terminated
- June 17, 2024
- Product code
- QKP – Coronavirus Antigen Detection Test System.
- Quantity
- 162,000 ea
- Distribution
- US Nationwide distribution in the state of CA.
- Recalling firm
- Celltrion USA Inc, Jersey City, NJ