Date Initiated by Firm |
November 20, 2014 |
Date Posted |
December 23, 2014 |
Recall Status1 |
Terminated 3 on May 20, 2015 |
Recall Number |
Z-0855-2015 |
Recall Event ID |
69856 |
Product Classification |
System, test, blood glucose, over the counter - Product Code NBW
|
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. |
Code Information |
U14030713, 814031313, U140312323, and U14031413. |
Recalling Firm/ Manufacturer |
Unistrip Technologies LLC 301 Mccullough Dr Suite 400 Charlotte NC 28262-3310
|
For Additional Information Contact |
Richard F. Admani 866-861-8066
|
Manufacturer Reason for Recall |
Failure to submit a 510(k) for device labeling changes.
|
FDA Determined Cause 2 |
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 in Commerce |
7175 units |
Distribution |
US Distribution to the states of FL and OH. |
Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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