Counterfeit Product Alert

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

 

December 17, 2013

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

 

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.

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.