Class I - Dangerous
Point of Care (PoC) rapid test products were distributed to customers who did not have a valid CLIA ID.
CELLTRION USA
Class I - Dangerous
Kits were labeled with incorrect expiration dates.
Class I - Dangerous
The affected lot was placed under quarantine in September 2021 due to complaints of alleged false positives, but 243 kits were erroneously released to customers in December 2021.
Class I - Dangerous
Returned test kits were erroneously shipped to customers. The kits are intended for Research Use Only (RUO). Additional RUO test kits were shipped to customers unlikely to use them for RUO purposes, and the firm provided a letter assuring distributors that RUO tests could be used for clinical diagnosis.
Class I - Dangerous
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.