Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Celltrion DiaTrust COVID-19 Ag Rapid Test Recalled by CELLTRION USA INC Due to The European version of the DiaTrust COVID-19 Ag...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact CELLTRION USA INC directly.
Affected Products
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.
Quantity: 162,000 ea
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About CELLTRION USA INC
CELLTRION USA INC has 5 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report