Recall Z-2730-2015 ยท GWN Nystagmograph
Neuro Kinetics, Inc.
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.
| Date | Sep 3, 2015 (initiated Jul 21, 2015) |
| Status | Terminated |
| Reason | The devices that included the OVAR research test were not cleared for marketing and mTBI research package was sold with the incorrect investigational label. |
| Root cause | No Marketing Application |
| Action | 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 ne |
| Quantity | 45 |
| Distribution | Worldwide Distribution - US (nationwide) |
| FDA record | Open on fda.gov |