Neuro Kinetics I-Portal NOTC System Recalled for Incorrect Investigational Labeling
Neuro Kinetics is recalling 45 I-Portal NOTC systems because the OVAR research test was sold with an incorrect investigational label.
The agency’s classification
FDA (Devices): Class II
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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text identifies the issue as an incorrect investigational label and lack of marketing clearance rather than a physical defect causing injury. This aligns with the rubric for minor labeling errors or voluntary precautionary recalls.
Plain-English summary
Neuro Kinetics, Inc. is recalling 45 units of the I-Portal NOTC system, a rotary chair used for vestibular and neuro-otologic diagnostic testing. The recall involves specific models, the I-Portal NOTC-O and I-Portal NOTC-C, which were distributed nationwide in the United States.
The recall was initiated because the devices included the OVAR research test, which has not yet been cleared by the FDA. The OVAR test was sold with an incorrect investigational label, and the devices were not cleared for marketing. The device provides no diagnoses or diagnostic recommendations.
Consumers who possess these specific serial numbers should contact Neuro Kinetics, Inc. for instructions on how to proceed. The affected units are identified by a specific list of serial numbers provided in the official recall notice.
The recalled product
- Product
- 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…
- Manufacturer
- Neuro Kinetics, Inc.
- Hazard
- Affected units
- 45
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- models: I-Portal¿ NOTC-O I-Portal¿ NOTC-C
Distribution
Distributed nationwide across the United States.
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