Critical Diagnostics

FDA Regulatory Profile

Critical Diagnostics appears in FDA public data with 1 recall, 0 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2012-2012, Class III) was initiated on February 28, 2012.

Summary

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

Recent Recalls

NumberClassProductDate
Z-2012-2012Class IIIPresage ST2 Assay, catalog numbers BC-1065 and BC-1065E. The Critical Diagnostics Presage ST2 AssFebruary 28, 2012