Neuro Kinetics I-Portal Normative Data Template CD Recalled for Lack of FDA Clearance
Neuro Kinetics is recalling 148 Normative Data Template CDs for I-Portal devices because the data has not received FDA clearance through the 510(k) process.
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 does not report any illnesses, injuries, or hospitalizations. The hazard is a regulatory compliance issue (lack of clearance) rather than a direct physical injury risk, fitting the criteria for a moderate severity score.
Plain-English summary
Neuro Kinetics, Inc. is recalling 148 units of the Normative Data Template CD used with I-Portal devices. These devices are used to measure, record, or visually display the involuntary movements (nystagmus) of the eyeball. The affected software versions are 6.7.004, 6.8, 6.9, 6.10, 7.0, 7.0.1, and 7.1.
The recall was initiated because the data provided on the Normative Data Template CD has not received clearance by the FDA through the premarket 510(k) notification process. The products were distributed nationwide in the United States and in Canada.
Consumers and healthcare providers who possess these CDs should stop using them and contact Neuro Kinetics, Inc. for further instructions.
The recalled product
- Product
- Normative Data Template CD for use with the I-Portal devices. Used to measure, record, or visually display the involuntary movements (nystagmus) of the eyeball.
- Manufacturer
- Neuro Kinetics, Inc.
- Affected units
- 148
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 (6)
- Software versions affected: 6.7.004
- 6.8. 6.9
- 6.10
- 7.0
- 7.0.1
- and 7.1
Distribution
Distributed nationwide across the United States.
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