CELLTRION USA INC

FDA Regulatory Profile

Summary

Total Recalls
5 (3 Class I)
510(k) Clearances
0
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0953-2022Class ICelltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02April 1, 2022
Z-0731-2022Class IICelltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02February 25, 2022
Z-0659-2022Class ICelltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02December 28, 2021
Z-0680-2022Class ICelltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02December 2, 2021
Z-0558-2022Class IICelltrion DiaTrust COVID-19 Ag Rapid Test, REF CT-P60 D-2 01. Contains 25 disposable test tubes withDecember 1, 2021