Recall Z-0855-2015
Unistrip Technologies LLC · initiated November 20, 2014
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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.
Codes / lots: U14030713, 814031313, U140312323, and U14031413.
Reason for recall
Failure to submit a 510(k) for device labeling changes.
FDA-determined cause: No Marketing Application
Action taken
UniStrip Technologies sent an Urgent Device Recall letter dated November 20, 2014, to all affected customers. They were instructed to immediately inform any of their retail accounts of the recall and have them return any of the recalled product to the distributor. The product is then to be returned to Unistrip Technologies. A reply form was included to be completed by the retail accounts and returned to the distributor who would in turn return the form to Unistrip Technologies to track returns. If you have any further questions, please call 1-866-861-8066.
Details
- Recall number
- Z-0855-2015
- Initiated
- November 20, 2014
- Posted by FDA
- December 23, 2014
- Terminated
- May 20, 2015
- Product code
- NBW – System, Test, Blood Glucose, Over The Counter
- Quantity
- 7175 units
- Distribution
- US Distribution to the states of FL and OH.
- Recalling firm
- Unistrip Technologies LLC, Charlotte, NC