medical Class II Updated 2022-02-09

CELLTRION USA INC recalls Celltrion DiaTrust COVID-19 Ag Rapid Test, REF CT-P60 D-2 01

Recalled 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.


Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: All lots
View official government recall

Looking for safe alternatives?

Browse certified-safe products in this category on Amazon →