Recall Z-2736-2018— Hudson Scientific LLC
Class II · Terminated
Class II FDA medical device recall by Hudson Scientific LLC, initiated 2018-07-02, terminated 2020-01-13. FDA's recall record names no specific 510(k) clearance for this event. 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: 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..
- Recalling firm
- Hudson Scientific LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-07-02
- Terminated
- 2020-01-13
- Firm location
- Hudson, MI, United States
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.