Z-2730-2015 Class II Terminated
FDA device recall Z-2730-2015 was initiated by Neuro Kinetics, Inc. on July 21, 2015 and is designated Class II. 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. The recall status is terminated (terminated September 27, 2016). Affected quantity: 45.
Recall Details
- Product Type
- Devices
- Report Date
- September 9, 2015
- Initiation Date
- July 21, 2015
- Termination Date
- September 27, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 45
Product Description
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.
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 Pattern
Worldwide Distribution - US (nationwide)
Code Information
models: I-Portal¿ NOTC-O I-Portal¿ NOTC-C, with S/N 890739 S/N 900140 S/N 900133 S/N 900114 S/N 900172 S/N 900136 S/N 900162 S/N 900134 S/N 900137 S/N 900147 S/N 890739 S/N 900140 S/N 900169 S/N 890738 S/N 900133 S/N 900118 S/N 900127 S/N 900138 S/N 900163 S/N 890742 S/N 890773 S/N 900155 S/N 900150 S/N 900158 S/N 900125 S/N 900123 S/N 900108 S/N 900114 S/N 900160 S/N 900168 S/N 900102 S/N 900130 S/N 900131 S/N 900128 S/N 900144 S/N 890741 S/N 890726 S/N 890736 S/N 900145 S/N 900111 S/N 900119