Celltrion USA Inc FDA Recalls

5 recalls on file across devices, 3 of them Class I and 1 still open. This firm is not matched to a listed company.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product	Reason	Class	Initiated
Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02Class IApr 1, 2022Point of Care (PoC) rapid test products were distributed to	Point of Care (PoC) rapid test products were distributed to customers who did not have a valid CLIA ID.	Class IDevices	Apr 1, 2022
Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02Class IIFeb 25, 2022Kits were labeled with incorrect expiration dates.	Kits were labeled with incorrect expiration dates.	Class IIDevices	Feb 25, 2022
Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02Class IDec 28, 2021The affected lot was placed under quarantine in September 20	The affected lot was placed under quarantine in September 2021 due to complaints of alleged false positives, b	Class IDevices	Dec 28, 2021
Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02Class IDec 2, 2021Returned test kits were erroneously shipped to customers. Th	Returned test kits were erroneously shipped to customers. The kits are intended for Research Use Only (RUO). A	Class IDevices	Dec 2, 2021
Celltrion DiaTrust COVID-19 Ag Rapid Test, REF CT-P60 D-2 01. Contains 25 disposable test tubes with extraction buffer, Class IIDec 1, 2021The European version of the DiaTrust COVID-19 Ag Rapid Test	The European version of the DiaTrust COVID-19 Ag Rapid Test is not approved for marketing in the U.S. but was	Class IIDevices	Dec 1, 2021