Iris Diagnostics

FDA Regulatory Profile

Summary

Total Recalls
4
510(k) Clearances
2
Inspections
3
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2441-2015Class IIiChemVELOCITY Automated Urine Chemistry Catalog No. 800-3049, 800-3050, 800-3079, 800-3080, 800-3530July 15, 2015
Z-0857-2015Class IIRTH8 Rotor, P/N X01-005847-001. RTH8 used in the StatSpin Express 4 Horizontal Centrifuge, Model M5December 3, 2014
Z-1328-2013Class IIIris Diagnostics Division iQ Control/Focus Set, Part Number 800-3104, Lot Number 153-12. Product September 18, 2012
Z-2124-2012Class IIIIRISpec" CA/CB two-part urine chemistry control twin set, Iris Diagnostics part number 800-0074. July 9, 2012

Recent 510(k) Clearances

K-NumberDeviceDate
K091539IQ 200 URINE ANALIZER BODY FLUIDS MODULEAugust 31, 2010
K072640IRISPEC,CA/CB/CCDecember 21, 2007