Z-2736-2018 Class II Terminated
FDA device recall Z-2736-2018 was initiated by Hudson Scientific LLC on July 2, 2018 and is designated Class II. 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 … The recall status is terminated (terminated January 13, 2020). Affected quantity: 35,949 units.
Recall Details
- Product Type
- Devices
- Report Date
- August 15, 2018
- Initiation Date
- July 2, 2018
- Termination Date
- January 13, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 35,949 units
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.
Distribution Pattern
Nationwide distribution. Worldwide distribution.
Code Information
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