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

FDA device recall Z-2730-2015 · posted 2015-09-03 · Terminated

Recall details

Recalling firm

Neuro Kinetics, Inc.

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.

Action taken

Neuro Kinetics sent notification letters to end users on/about July 24, 2015, to alert them to the reason for recall and inform them of the corrective action planned by Neurokinetics. Action to be taken by you the Customer/User: If you have already initiated OVAR research (an IRB approved study with non-significant risk designation is ongoing), please reply to this email and include a copy of the IRB approval letter or the IRB approval information (e.g., investigators name, IRB name, IRB location, and study reference number). In return, NKI will mail you a field correction package with the necessary and appropriate Investigational Device labeling. If you have not initiated OVAR research (an IRB approved study is not ongoing), please discontinue use of the OVAR test and reply to this email to confirm that you are not using the OVAR test as part of an IRB approved study. In return, NKI will mail you a field correction package to disable the OVAR test functionality, which can be restored at the time you have an IRB approved study. Disabling the OVAR research test will have no effects on the functionality of the clinical tests included with your NOTC system. There will be no perceivable changes to the system outside of not being able to run the OVAR test. For questions regarding this recall call 412-963-6649.

Root cause

No Marketing Application

Status

Terminated

Product code

GWN

Quantity affected

45

Distribution

Worldwide Distribution - US (nationwide)

Date initiated

2015-07-21

Date posted

2015-09-03

Date terminated

2016-09-27

Location

Pittsburgh, PA

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