Reported Feb 19, 2014 · Terminated
Normative Data Template CD for use with the I-Portal devices. Used to measure, record, or visually display the…
Neuro Kinetics, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Neuro Kinetics, Inc. · 128 Gamma Dr · Pittsburgh, PA · 15238-2920
Is this the product you have?
- 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.
- Lot codes and dates
- Software versions affected
6.7.0046.8. 6.96.107.07.0.1and 7.1
- Software versions affected
- Amount recalled
- 148
Where it was sold
- Nationwide
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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