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.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Software versions affected: 6.7.004, 6.8. 6.9, 6.10, 7.0, 7.0.1, and 7.1
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Neuro Kinetics, Inc.
- Reason for Recall:
- The data provided on the Normative Data Template CD for use with the I-Portal devices has not received clearance by FDA through the premarket 510(k) notification process.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
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.
Product Codes/Lot Numbers:
Software versions affected: 6.7.004, 6.8. 6.9, 6.10, 7.0, 7.0.1, and 7.1
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0966-2014
Related Recalls
The devices that included the OVAR research test were not cleared for marketing and mTBI research package was sold with the incorrect investigational label.
complaints of system malfunction and unintended, sudden movement at start up. No injuries reported.