Neuro Kinetics, Inc. recalls Neuro Kinetics, Inc. (NKI) I-Portal¿ NOTC system with the OVAR research test; a rotary chair system used in vestibular…

Recall date

July 21, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2730-2015

FDA classification

Class II

Brand / firm

Neuro Kinetics, Inc.

Sold / distributed

Worldwide Distribution - US (nationwide)

Why it was recalled

The devices that included the OVAR research test were not cleared for marketing and mTBI research package was sold with the incorrect investigational label.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.