Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.
Celltrion DiaTrust COVID-19 Ag Rapid Test Recalled by CELLTRION USA INC Due to Returned test kits were erroneously shipped to customers....
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, Reference No. CT-P60 D-2 02
Quantity: 8080 kits originally distributed; 726 kits redistributed
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed to 1 state: TX
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