medical Class II Updated 2018-08-15

Hudson Scientific LLC recalls iTOVi Tracker/Scanner, Model Nos. ITS10 and ITS15 Intended

Recalled 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.

Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Device Lot/ Batch Numbers: 012016, 032016, 112016, 122016, 012017, 022017, 032017, 092017, 112017, 012018 Device Serial Numbers: 35,949 MAC Numbers ranging from 0F:72: D9:E9: F4:5A to FF: FF: AB:37: 7A:0C
View official government recall

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