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
Lot COVGCCM0008
Products Sold
Lot COVGCCM0008
CELLTRION USA INC is recalling Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02 due to The affected lot was placed under quarantine in September 2021 due to complaints of alleged false positives, but 243 kits were erroneously released to. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
The firm initially placed a hold on product due to complaints of false positive and false negative results in September 2021. After product was erroneously distributed from this lot in December 2021, the firm notified affected customers that the lot should not have been distributed and should not be used. This email went out on or around December 28, 2021. Customers were instructed to NOT use the affected lot.
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
CA, FL, NJ, NY, PA, SC
Page updated: Jan 10, 2026