QUIDELORTHO

FDA Regulatory Profile

Summary

Total Recalls
2
510(k) Clearances
0
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1819-2024Class IIVITROS Immunodiagnostic Products Free T3 Calibrators-IVD are for use with Free T3 Reagent Pack for tApril 9, 2024
Z-1818-2024Class IIVITROS Immunodiagnostic Products Free T3 Reagent Pack-IVD is for the quantitative measurement of freApril 9, 2024