Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-2730-2015 — Neuro Kinetics, Inc. (NKI) I-Portal¿ NOTC system with the OVAR research test; a rotary chair system used in vestibular and neuro-otologic diagnostic testing. This device provides no diagnoses nor does it provide diagnostic recommendations.The OVAR test has not yet been cleared by the FDA, and until

U.S. FDA — Device Enforcement · United States · 2015-07-21 · Class II

AI-assisted, human-edited — this page is drafted with AI from public-source data, then reviewed before publication. How we use AI →

Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2730-2015
Date of alert: 2015-07-21
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Neuro Kinetics, Inc.
Product category: device
Product type: Devices

Reported risk: The devices that included the OVAR research test were not cleared for marketing and mTBI research package was sold with the incorrect investigational label.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

Related