QUIDELORTHO

FDA Regulatory Profile

QUIDELORTHO appears in FDA public data with 2 recalls, 0 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1818-2024, Class II) was initiated on April 9, 2024.

Summary

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

Recent Recalls

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