Illegally Relabeled and Potentially Expired and Mishandled OneTouch® Ultra® Blood Glucose Test Strips discovered in Nepal
August 29, 2014
If you use, recommend, distribute or sell OneTouch® Brand Test Strips, we want to make you aware that we have recently discovered illegally relabeled OneTouch®Ultra® Blood Glucose Test Strips in Nepal.
Although these test strips were originally manufactured by LifeScan, an unauthorized third party has illegally obtained these test strips and relabeled and repackaged them for sale in Nepal. It is unknown if these test strips are expired or have otherwise been mishandled by exposure to heat or humidity – all factors that could negatively impact the accuracy of their test results.
This issue does not involve OneTouch® Select® Test Strips.
Potential Risk To Patients
These illegally relabeled OneTouch®Ultra® Test Strips should not be used under any circumstances to test blood glucose. Testing of some illegally relabeled products has shown unreliable performance that includes highly inaccurate test results. It is unknown how the illegally relabeled test strips in Nepal will perform. LifeScan cannot ensure the accuracy and reliability of blood glucose test results obtained from illegally relabeled test strips. Use of these illegally relabeled test strips could result in inaccurate test results that may lead to improper treatment. Notably, insulin treatment based on inaccurate blood glucose results could result in serious injury or death.
Identifying Illegally Relabeled OneTouch®Ultra® Test Strips
By Lot Number:
All OneTouch®Ultra® Test Strips with the lot number 3244696 have been illegally relabeled and should not be used. This is not a valid lot number.
The lot number is located on both the test strip carton and vial label.
Outer Carton: Genuine products have a closure seal
Vial Label: “Ultra” is misspelled as “Ultraa”
What You Should Do
We recommend that you routinely check your OneTouch®Ultra® Test Strips. If you determine you have illegally relabeled product, or require assistance, please call LifeScan Customer Service at: 1800225544 or 022-30845544.
Patients with illegally relabeled 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.
How LifeScan Is Addressing This Issue
Patient safety is our top concern. We are working closely with authorities to prevent illegally relabelled test strips from entering Nepal. We are also alerting distributors and healthcare professionals of this issue and will continue to monitor the market. Any merchant, healthcare professional or patient that discovers illegally relabeled test strips is encouraged to report their finding to LifeScan
Notifications may be found at: www.GenuineOneTouch.com. We recommend you visit this Web page periodically for important Product Alerts or updates that may be issued in the future. If you have any questions or concerns about your OneTouch®Ultra® Test Strips, please contact LifeScan Customer Service at 1800225544 or 022-30845544.