Tosoh Smd Inc

FDA Regulatory Profile

Summary

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

Recent Recalls

NumberClassProductDate
Z-0745-2020Class IIIAIA-PACK B12 Pretreatment Set- IVD for diagnostic use for pre-treatment of calibrators/controls. ParNovember 15, 2019
Z-1245-2017Class IIKeyspan High-High Speed USB to Serial Adapter Product Usage: The Reporting Software is an applicDecember 22, 2016
Z-1830-2013Class IIAIA Analyzer Pipette Tips used on Tosoh AIA-2000, AIA-1800, AIA-900 and AIA-600II Analyzers, 1000 tiMay 15, 2013