Sysmex Corporation

FDA Regulatory Profile

Sysmex Corporation appears in FDA public data with 1 recall, 0 510(k) clearances, 2 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1945-2016, Class II) was initiated on December 18, 2014.

Summary

Total Recalls
1
510(k) Clearances
0
Inspections
2
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1945-2016Class IIThe XN-Series modules (XN-10, XN-20) are quantitative multi-parameter automated hematology analyzersDecember 18, 2014