Recall Z-0855-2015 ยท NBW System, Test, Blood Glucose, Over The Counter
Unistrip Technologies LLC
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.
| Date | Dec 23, 2014 (initiated Nov 20, 2014) |
| Status | Terminated |
| Reason | Failure to submit a 510(k) for device labeling changes. |
| Root cause | No Marketing Application |
| Action | 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. |
| Quantity | 7175 units |
| Distribution | US Distribution to the states of FL and OH. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.