Counterfeit Product Alert

Counterfeit Product Alert

Counterfeit ONETOUCH® Ultra® and ONETOUCH® Horizon® Blood Glucose Test Strips discovered in India

January 7, 2015

If you use, recommend, distribute or sell OneTouch® Brand Test Strips, we want to make you aware that we have discovered counterfeit OneTouch® Ultra® and OneTouch® Horizon® Blood Glucose Test Strips in India. A counterfeit product is a fake product not made by LifeScan.

This issue does not involve OneTouch® Select® or OneTouch® SureStep® Test Strips.

Potential Risk To Patients

Testing of these counterfeit test strips has shown unreliable performance that includes highly inaccurate test results. It is unknown how counterfeit test strips that may be in the marketplace will perform. LifeScan cannot ensure the accuracy and reliability of blood glucose test results obtained from a OneTouch® Meter using counterfeit test strips. Use of these counterfeit 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 Counterfeit OneTouch® Brand Test Strips

We have discovered counterfeit test strips among the following lots of genuine OneTouch® Ultra® and OneTouch® Horizon® Test Strips sold in India. We recommend you routinely check your test strips to determine if they are counterfeit. Test Strips with the following lot numbers are counterfeit if any of the information listed below Does Not match.

Genuine OneTouch® Ultra® Test Strip Features

Lot Number Calcode Expiry Date Control Range "OneTouch"
printed on Strip
3346193 25 02/2014 6.7-8.9 mmol/L
121-161 mg/dL
YES
3263233 25 08/2013 5.6-7.4 mmol/L
100-134 mg/dL
YES
3301545 25 11/2013 6.7-8.9 mmol/L
120-160 mg/dL
YES
3541366 25 04/2015 113-150 mg/dL
6.3-8.3 mmol/L
YES

Genuine OneTouch® Horizon® Test Strip Features

Lot Number Calcode Expiry Date Control Range
3305057 19 12/2013 5.8-7.9 mmol/L
105-142 mg/dL
3357446 31 02/2014 5.9-8.0 mmol/L
107-144 mg/dL

Additional Features Look For

Product Pack – OneTouch® Ultra® and OneTouch® Horizon®

  • Tamper Evident MRP Label - All genuine test strip packaging, regardless of lot number, have a blue colored Tamper Evident MRP Label, which once peeled off would reveal the words "OPEN" twice. If it does not say OPEN, the pack is counterfeit. See photos (Annex. 1)
  • Scratch label - All genuine test strips packaging, regardless of lot number have a scratch label pasted on the side panel of the package containing OneTouch® Zone Number. This label when scratched would reveal a unique number which can be verified by calling LifeScan Customer Service at: 1-800-22-5544 (Toll Free from MTNL and BSNL landlines) who would instantly confirm, if the pack is genuine or not. See photos (Annex. 1)

Test Strip - OneTouch® Ultra® Only

  • All genuine OneTouch® Ultra® Test Strips regardless of lot number have the OneTouch® Trademark printed on them. If your OneTouch® Ultra® Test Strips do not say “OneTouch®, they are counterfeit.

     

    Note: Genuine OneTouch® Horizon® Test Strips Do Not have "OneTouch®" printed on them.
Genuine
Counterfeit

What You Should Do

If you determine you have counterfeit test strips, or require assistance, please call LifeScan Customer Service at: 1-800-22-5544 (Toll Free from MTNL and BSNL landlines) or between 8:00 am to 8:00 pm, Monday through Sunday.

We recommend that you routinely check your OneTouch® Ultra® and OneTouch® Horizon® Test Strips. Patients with counterfeit test strips should discontinue their use immediately and replace them with genuine OneTouch® Brand Test Strips. Patients should also contact their physician to assess potential treatment implications.

How LifeScan Is Addressing This Issue

Dealing in counterfeit test strips is a legal offence. LifeScan is initiating legal actions (criminal as well as civil) against persons dealing in counterfeit LifeScan products. We would request you to immediately inform us if you come across any person dealing in counterfeit LifeScan products.

LifeScan is also working closely with the Drugs Controller General of India and Customs to prevent counterfeit test strips from entering India. We are also alerting distributors, wholesalers and patients of this issue.

Notifications may also 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® Ultra® or OneTouch® Horizon® Test Strips, please contact LifeScan at 1-800-22-5544 (Toll Free from MTNL and BSNL landlines) or between 8:00 am to 8:00 pm, Monday through Sunday.