CELLTRION USA INC 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
CELLTRION USA INC
Lot Codes / Batch Numbers
All lots
Products Sold
All lots
CELLTRION USA INC is recalling Celltrion DiaTrust COVID-19 Ag Rapid Test, REF CT-P60 D-2 01. Contains 25 disposable test tubes with due to 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 pa. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026