Data Innovations, LLC

FDA Regulatory Profile

Summary

Total Recalls
4
510(k) Clearances
0
Inspections
1
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0203-2019Class IIIM Abbott Alinity ci-series (abdicqii) accessory driver v8.00.0001 software product that can receiveAugust 29, 2018
Z-1680-2017Class IIJResultNet drivers using ASTM coding language. Calculator/data processing module, for clinical use October 23, 2014
Z-2637-2014Class IIProVue Instrument Driver for JResultNet (ProVue.jrm) v. 1.5.3 and below JResultNet is a stand-aloAugust 15, 2014
Z-0571-2014Class IIInstrument Manager driver : Driver sysu100i that connects to the Sysmex UF-100 analyzer Software November 6, 2013