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CELLTRION USA INC recalls Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02
Recalled March 9, 2022 · FDA recall Z-0680-2022 · CELLTRION USA
Hazard
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. · FDA Class I
Units
8080 kits originally distributed; 726 kits redistributed
Sold at
Distributed to TX.
Description
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.
Product
Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02
Manufacturer(s)
CELLTRION USA INC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →