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,…

Recall date

December 1, 2021

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0558-2022

FDA classification

Class II

Brand / firm

CELLTRION USA INC

Sold / distributed

US Nationwide distribution in the state of CA.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.