Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall UniStrip1

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall UniStrip1 see related information
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
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.
-
-