Counterfeit OneTouch® Ultra® Blood Glucose Test Strips Discovered in Greece
Updated: December 2, 2013
If you use, recommend, distribute or sell OneTouch® Brand Test Strips, we want to make you aware that we have recently discovered counterfeit OneTouch® Ultra® Blood Glucose Test Strips in Greece.Counterfeit product is fake product not made by LifeScan.
Counterfeit product is fake product not made by LifeScan. This issue does not involve OneTouch® Vita.
Potential Risk to Patients
Testing of these counterfeit test strips obtained by LifeScan has shown unreliable performance that includes highly inaccurate clinically significant test results. LifeScan cannot assure the accuracy and reliability of blood glucose test results obtained from test strips it did not manufacture. Use of these counterfeit test strips could result in inaccurate test results that may lead to improper treatment. For example, insulin treatment based on inaccurate blood glucose results could result in serious injury or death.
Identifying Counterfeit OneTouch® Ultra® Test Strips
The counterfeit test strips and their packaging that we have detected can be identified by the following characteristics:
By Lot Number:
All 50-Count OneTouch® Ultra® Test Strips with the following Lot numbers are counterfeit:
32428691 3268762 3243186 3107622 3228064 3228631 353885711500
- The lot number is located on both the test strip carton and vial label.
Locating Lot Numbers
|Counterfeit Carton||Counterfeit Vial|
By Lot Number + Additional Features:
50-Count OneTouch® Ultra® Test Strips with Lot number: 3275176 are counterfeit if they also have the following additional characteristics:
- Outer Carton Closure Seal: The "®" symbol appears with the word "LifeScan®" on the Closure Seal. For all genuine OneTouch® Ultra® Test Strips the "®" symbol does not appear with the word "LifeScan."
- Vial: The Cal Code is not "25." All genuine OneTouch® Ultra® Test Strips are Cal Code "25."
- Test Strip: The "OneTouch®" Trademark appears as a paper label applied to the test strip. On genuine test strips, the "OneTouch®" trademark is printed directly on each test strip and cannot be removed.
Note: 3275176 is a genuine lot number so it’s important that you check all test strips with this lot number for these additional identifying characteristics to confirm they are counterfeit.
What You Should Do
We recommend that you routinely check your OneTouch® Ultra® Test Strips. Patients with counterfeit test strips should discontinue their use immediately and replace them with genuine OneTouch® Ultra® Test Strips. Patients should also contact their physician to assess potential treatment implications.
If you determine you have counterfeit test strips, or require assistance, please call LifeScan Customer Service at: 800 11 78 888 (toll-free number).
How LifeScan Is Addressing This Issue
LifeScan is working closely with the National Organization for Medicines (Greek Regulatory Body) to prevent counterfeit test strips from entering Greece. We are also alerting distributors, retailers, healthcare professionals and consumers of this issue.
Notifications may be found at: www.GenuineOneTouch.com. We recommend you visit this Web page periodically for important Counterfeit Product Alerts or updates that may be issued in the future. If you have any questions or concerns about your OneTouch® Utlra® Test Strips, please contact LifeScan at: 800 11 78 888 (toll-free number).