Counterfeit Test Strips Discovered in United States: OneTouch(R) Ultra(R) and OneTouch(R) Basic(R)/Profile(R) Test Strips

Oct 13, 2006, 01:00 ET from LifeScan, Inc.

    MILPITAS, Calif., Oct. 13 /PRNewswire/ -- LifeScan, Inc., a Johnson &
 Johnson company and makers of the OneTouch(R) Brand of diabetes testing
 supplies, has identified several incidents of counterfeit OneTouch(R)
 Ultra(R) and OneTouch(R) (Basic(R)/Profile(R)) Test Strips. These test
 strips being sold in the United States are intended for use with various
 models of LifeScan's OneTouch(R) 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
     (Photo: )
     -- 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
     (Photo: )
     -- Multiple Languages-English, Greek and Portuguese text on the outer
     -- 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
     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 1-866-621-4855. In addition, any patient or healthcare
 professional that discovers counterfeit products should file a report with
 FDA's MedWatch program by visiting: or
 calling 1-800- 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
     (1) The counterfeit OneTouch Ultra Test Strips are intended for use with
         the OneTouch(R) Ultra(R), OneTouch(R) Ultra(R) 2, OneTouch(R)
         UltraSmart(R), and OneTouch(R) UltraMini(TM) Blood Glucose Monitoring
         The counterfeit OneTouch (Basic/Profile)Test Strips are intended for
         use with the OneTouch(R) Basic(R), OneTouch(R) Profile(R) and
         OneTouch(R) II Blood Glucose Monitoring Systems.

SOURCE LifeScan, Inc.