medical Class I Updated 2022-03-09

CELLTRION USA INC recalls Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-

Recalled Product

Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02


Hazard / Issue

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.

Issued by

FDA

Affected States: TX
Lot/Code Info: Lots COVGCCF0001, COVGCCF0002
View official government recall

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