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.
- Company
- Celltrion Usa Inc
- Recall Initiated
- December 1, 2021
- Terminated
- June 17, 2024
- Recall Number
- Z-0558-2022
- Quantity
- 162,000 ea
- Firm Location
- Jersey City, NJ
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.
Distribution
US Nationwide distribution in the state of CA.
Lot / Code Info
All lots
Root 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.