Recall Z-0558-2022— CELLTRION USA INC
Class II · Terminated
Class II FDA medical device recall by CELLTRION USA INC, initiated 2021-12-01, terminated 2024-06-17. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: 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..
- Recalling firm
- CELLTRION USA INC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2021-12-01
- Terminated
- 2024-06-17
- Firm location
- Jersey City, NJ, United States
Product description
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.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.