ITOVi Tracker/Scanner recalled over manufacturing violations

Recall date

July 2, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Hudson Scientific LLC recalls iTOVi Tracker/Scanner, Model Nos. ITS10 and ITS15 Intended to rank galvanic skin response measurements. The results are…

Recall number

Z-2736-2018

FDA classification

Class II

Brand / firm

Hudson Scientific LLC

Sold / distributed

Nationwide distribution. Worldwide distribution.

Why it was recalled

The device and its accessories may not have been manufactured according to current Good Manufacturing Practices. In addition, the firm has received three complaints regarding electric shocks received when using the device.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

iTOVi Tracker/Scanner, Model Nos. ITS10 and ITS15 Intended to rank galvanic skin response measurements. The results are used by the software to generate a report that then makes a recommendation on nutritional supplements.