FDA recall Z-2736-2018

Hudson Scientific LLC · Class II · device

Product

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.

Reason for recall

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.

Distribution

Nationwide distribution. Worldwide distribution.

Key facts

Status
Terminated
Initiation date
2018-07-02
Report date
2018-08-15
Termination date
2020-01-13
Voluntary/Mandated
Voluntary: Firm initiated
Location
Hudson, MI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2736-2018