CELLTRION USA INC Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02
Brand
CELLTRION USA INC
Lot Codes / Batch Numbers
Lots COVGCCF0001, COVGCCF0002
Products Sold
Lots COVGCCF0001, COVGCCF0002
CELLTRION USA INC is recalling Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02 due to Returned test kits were erroneously shipped to customers. The kits are intended for Research Use Only (RUO). Additional RUO test kits were shipped to . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
On December 2, 2021, the firm notified the affected distributor that the two lots are Research Use Only and should not be used. The distributor then notified the customer. Customer reported all product had been used.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
TX
Page updated: Jan 10, 2026