Oxford Immunotec

FDA Regulatory Profile

Summary

Total Recalls
5
510(k) Clearances
0
Inspections
1
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1643-2022Class IIAIM-V Medium REF AV.200/500July 7, 2022
Z-1642-2022Class IIT-Cell Xtend REF TTK.610 USJuly 7, 2022
Z-1641-2022Class IIT-SPOT.TB REF TB.300 USJuly 7, 2022
Z-2976-2020Class IIIModel No:T-SPOT.TB8, Catalogue No.: TB.300; UDI: 1505171600030 - Product Usage: intended for use as July 16, 2020
Z-2977-2020Class IIIModel No:T-SPOT.TB50, Catalogue No.: TB.50; UDI: 1505171600004 - Product Usage: intended for use as July 16, 2020