FDADecember 1, 2021device
Celltrion 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.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
The European version of the DiaTrust COVID-19 Ag Rapid Test is not approved for marketing in the U.S. but was illegally distributed in the U.S. The packaging and labeling of the European test kit is different from the US test kit and is NOT authorized for distribution in the US.
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, Reference No. CT-P60 D-2 022021-12-02
Own something like this?
AllClear screens your whole list against every CPSC, FDA, USDA and NHTSA recall — and tells you the day a new one names something you own.
Start free — 200 items, no card →