FDADecember 2, 2021device
Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02
Official recall recorded by the U.S. Food & Drug Administration.
The 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.
What to do
FDA enforcement status: Terminated
Brands named
celltrion
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDACelltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 022022-04-01
- FDACelltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 022022-02-25
- FDACelltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 022021-12-28
- FDACelltrion DiaTrust COVID-19 Ag Rapid Test, REF CT-P60 D-2 01. Contains 25 disposable test tubes with extraction buffer, 25 filter caps, 25 sterilized swabs per box.2021-12-01
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