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Neuro Kinetics, Inc. recalls Normative Data Template CD for use with the I-Portal devices. Used to measure, record, or visually display the involu
Recalled February 19, 2014 · FDA recall Z-0966-2014 · Neuro Kinetics
Hazard
The data provided on the Normative Data Template CD for use with the I-Portal devices has not received clearance by FDA through the premarket 510(k) notification process. · FDA Class II
Units
148
Sold at
Distributed USA (nationwide) and the country of Canada.
Description
The data provided on the Normative Data Template CD for use with the I-Portal devices has not received clearance by FDA through the premarket 510(k) notification process.
Product
Normative Data Template CD for use with the I-Portal devices. Used to measure, record, or visually display the involuntary movements (nystagmus) of the eyeball.
Manufacturer(s)
Neuro Kinetics, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →