FDADecember 28, 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
The affected lot was placed under quarantine in September 2021 due to complaints of alleged false positives, but 243 kits were erroneously released to customers in December 2021.
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 022021-12-02
- 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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