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: http://www.newscom.com/cgi-bin/prnh/20061013/NYF098-a )
-- 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: http://www.newscom.com/cgi-bin/prnh/20061013/NYF098-b )
-- 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 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 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: http://www.fda.gov/medwatch/What.htm 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.