Z-0855-2015 Class II Terminated
FDA device recall Z-0855-2015 was initiated by Unistrip Technologies LLC on November 20, 2014 and is designated Class II. Reason for recall: Failure to submit a 510(k) for device labeling changes. The recall status is terminated (terminated May 20, 2015). Affected quantity: 7175 units.
Recall Details
- Product Type
- Devices
- Report Date
- December 31, 2014
- Initiation Date
- November 20, 2014
- Termination Date
- May 20, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 7175 units
Product Description
UniStrip1, Blood Glucose Test Strips, 50 count box. The test strips are indicated for use by people with diabetes in their home as an aid to monitor the effectiveness of diabetes control.
Reason for Recall
Failure to submit a 510(k) for device labeling changes.
Distribution Pattern
US Distribution to the states of FL and OH.
Code Information
U14030713, 814031313, U140312323, and U14031413.