Normative Data Template CD for use with the I-Portal devices — Class II medical device recall Z-0966-2014
Terminated recall by Neuro Kinetics, Inc., reported 2014-02-19, distributed nationwide. The data provided on the Normative Data Template CD for use with the I-Portal devices has not received clearan
| Recall number | Z-0966-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Neuro Kinetics, Inc., Pittsburgh, PA, United States |
| Recall initiated | 2013-11-21 |
| Classified | 2014-02-10 |
| Reported by FDA | 2014-02-19 |
| Terminated | 2015-07-20 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 148 |
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.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0966-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.