Reported Aug 15, 2018 · Terminated

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

Hudson Scientific LLC

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Hudson Scientific LLC · 103 W Main St · Hudson, MI · 49247-1022

Is this the product you have?

  • 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.
Lot codes and dates
  • Device Lot/ Batch Numbers
    • 012016
    • 032016
    • 112016
    • 122016
    • 012017
    • 022017
    • 032017
    • 092017
    • 112017
    • 012018
  • Device Serial Numbers
    • 35
    • 949
  • MAC Numbers ranging from 0F72:
  • D9E9:
  • F45A
  • to FFFF:
  • AB37: 7A:0C
Amount recalled
35,949 units

Where it was sold

  • Nationwide

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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Jan 13, 2020 · Data as of Sep 19, 4:44 PM UTC

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