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Neuro Kinetics, Inc. recalls Neuro Kinetics, Inc. (NKI) I-Portal¿ NOTC system with the OVAR research test; a rotary chair system used in vestibular a
Recalled September 9, 2015 · FDA recall Z-2730-2015 · Neuro Kinetics
Hazard
The devices that included the OVAR research test were not cleared for marketing and mTBI research package was sold with the incorrect investigational label. · FDA Class II
Units
45
Sold at
Worldwide Distribution - US (nationwide)
Description
The devices that included the OVAR research test were not cleared for marketing and mTBI research package was sold with the incorrect investigational label.
Product
Neuro Kinetics, Inc. (NKI) I-Portal¿ NOTC system with the OVAR research test; a rotary chair system used in vestibular and neuro-otologic diagnostic testing. This device provides no diagnoses nor does it provide diagnostic recommendations.The OVAR test has not yet been cleared by the FDA, and until then can only be used as an investigational device.
Manufacturer(s)
Neuro Kinetics, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →