FDA recall Z-0558-2022

CELLTRION USA INC · Class II · device

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 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.

Distribution

US Nationwide distribution in the state of CA.

Key facts

Status
Terminated
Initiation date
2021-12-01
Report date
2022-02-09
Termination date
2024-06-17
Voluntary/Mandated
Voluntary: Firm initiated
Location
Jersey City, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0558-2022