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Counterfeit Test Strips Discovered in United States: OneTouch® Ultra® and OneTouch® Basic®/Profile® Test Strips

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Milpitas, California, October 13, 2006. LifeScan, Inc., a Johnson & Johnson company and makers of the OneTouch® Brand of diabetes testing supplies, has identified several incidents of counterfeit OneTouch® Ultra® and OneTouch® (Basic®/Profile®) Test Strips. These test strips being sold in the United States are intended for use with various models of LifeScan's OneTouch® Brand Blood Glucose Monitors used by people with diabetes to measure their blood glucose.1

Performance testing of the counterfeit test strips obtained by LifeScan to date shows erratic test results that do not meet LifeScan's performance specifications. It is unknown how counterfeit test strips which may be in the marketplace will perform. LifeScan cannot ensure the accuracy and reliability of blood glucose test results obtained from test strips it did not manufacture. Patients should discontinue use of these counterfeit test strips and replace them immediately. Patients should also contact their physician to assess potential treatment implications. 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.

The outer cartons of the recently discovered counterfeit test strips have all of the following characteristics:

OneTouch Ultra Test Strips

  • Multiple Languages—English and French text on the outer carton;
  • Lot Number 2691191 (located on outer carton and vial); and
  • Limited to 50-Count OneTouch Ultra Test Strip packages.

OneTouch (Basic/Profile) Test Strips

  • Multiple Languages—English, Greek and Portuguese text on the outer
    carton;
  • Lot Numbers 272894A, 2619932 or 2606340 (located on outer carton and
    vial); and
  • Limited to 50-Count OneTouch (Basic/Profile) Test Strip packages.

A detailed description of this issue, specific information for merchants, and periodic updates are available at www.GenuineOneTouch.com.

Upon identifying these incidents, LifeScan immediately notified the Food and Drug Administration (FDA) and is vigorously pursuing legal actions. The company is also notifying wholesalers, distributors, retailers and pharmacists so that they can quickly identify and remove the counterfeit test strips from the market. Any merchant or patient who discovers counterfeit products is encouraged to report their finding by calling LifeScan at 866 621-4855. In addition, any patient or healthcare professional that discovers counterfeit products should file a report with FDA's MedWatch program by visiting: http://www.fda.gov/medwatch/What.htm or calling 800 FDA-1088.

LifeScan, Inc., a Johnson & Johnson company, and a leading maker of blood glucose monitoring products, is dedicated to creating a world without limits for people with diabetes. For healthcare professional resources, and information on diabetes care and LifeScan products and services, visit www.LifeScan.com.

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