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.
Recall
- Recall Number
- Z-0855-2015
- Event Number
- 69856
- Firm
- Unistrip Technologies LLC
- FEI Number
- 3010622184
- Product Code
- NBW
- Status
- Terminated
- Root Cause
- No Marketing Application
- Initiated
- November 20, 2014
- Posted
- December 23, 2014
- Terminated
- May 20, 2015
- Address
- 301 Mccullough Dr, Suite 400, Charlotte, NC, 28262-3310
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.
Failure to submit a 510(k) for device labeling changes.
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.
US Distribution to the states of FL and OH.
7175 units