Food, drugs, devices › Neuro Kinetics, Inc.
Device recall: Neuro Kinetics, Inc. (NKI) I-Portal¿ NOTC system with the OVAR research test; a rotary chair system used in vestibular a
Neuro Kinetics, Inc. (Pittsburgh, PA) initiated this device recall on 21 Jul 2015; FDA lists 1 product record under event 71832, classified Class II.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 91% of the 1,153 device enforcement events initiated in 2015 carry the same class.
Status: Terminated, terminated 27 Sep 2016. Initiation: voluntary: firm initiated. Neuro Kinetics, Inc. has 3 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Neuro Kinetics, Inc., Pittsburgh, PA.
Reason for recall
"The devices that included the OVAR research test were not cleared for marketing and mTBI research package was sold with the incorrect investigational label."
Distribution
"Worldwide Distribution - US (nationwide)"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2730-2015 | 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… | 45 | Class II | Terminated | 9 Sep 2015 |
Context
Other enforcement events for Neuro Kinetics, Inc.
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 30 Apr 2015 | I-Portal¿ NOTC and VNG; a device used to measure, record, or visually display the involuntary movements (nystagmus) of t | Device | Class II | 1 |
| 21 Nov 2013 | Normative Data Template CD for use with the I-Portal devices. Used to measure, record, or visually display the involunta | Device | Class II | 1 |
All 3 events for Neuro Kinetics, Inc.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "The devices that included the OVAR research test were not cleared for marketing and mTBI research package was sold with the incorrect investigational label."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Worldwide Distribution - US (nationwide)"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 27 Sep 2016. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.