Normative Data Template CD for use with the I-Portal recall
Normative Data Template CD for use with the I-Portal devices. Used to measure, record, or visually display the involuntary movements (nystagmus) of…
Why was Normative Data Template CD for use with the I-Portal recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Software versions affected: 6.7.004, 6.8. 6.9, 6.10, 7.0, 7.0.1, and 7.1
- Product
- Normative Data Template CD for use with the I-Portal devices. Used to measure, record, or visually display the involuntary movements (nystagmus) of…
- Recalling firm
- Neuro Kinetics, Inc.
- Quantity
- 148
- Distribution
- Distributed USA (nationwide) and the country of Canada.
- Recall date
- February 19, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)