FDA-Device2022-03-09Class I
Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02
CELLTRION USA INC
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.
Sold states
Distributed to TX.
Affected count
8080 kits originally distributed; 726 kits redistributed
Manufactured in
1 Evertrust Plz Ste 1207, Jersey City, NJ, United States
Products
Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0680-2022Don't want to check this manually?
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