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CELLTRION USA INC recalls Celltrion DiaTrust COVID-19 Ag Rapid Test, REF CT-P60 D-2 01. Contains 25 disposable test tubes with extraction buffer,
Recalled February 9, 2022 · FDA recall Z-0558-2022 · CELLTRION USA
Hazard
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 Class II
Units
162,000 ea
Sold at
US Nationwide distribution in the state of CA.
Description
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.
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.
Manufacturer(s)
CELLTRION USA INC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →