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Important Information about the OneTouch® Ultra® Blood Glucose Meter
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Counterfeit Test Strips Discovered in United States
OneTouch® Ultra® and OneTouch® Basic®/Profile® Test Strips |
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Updated: December 18, 2006
What's New: Added OneTouch Basic/Profile Lot #2662169.
Select the individual lot numbers for specific characteristics and images.
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October 13, 2006
If you use, recommend, distribute or sell OneTouch® Brand Test Strips, we want to make you aware that we have recently discovered several incidents of counterfeit OneTouch® Ultra®1, and OneTouch®2 (Basic®/Profile®) Test Strips in the United States.
This issue does not involve OneTouch® FastTake® or OneTouch® SureStep® Test Strips. Potential Risk to Patients
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. We have informed the Food and Drug Administration (FDA) and are vigorously pursuing legal actions.
Identifying Counterfeit Product
Counterfeit product is fake product not made by LifeScan. Counterfeit test strips may be identified by various characteristics. Select the lot number associated with each counterfeit test strip to see the associated characteristics. Please note that in some cases, only the lot number is known. Check back frequently for additional information and updates.
Counterfeit OneTouch Ultra Test Strip Lots
Counterfeit OneTouch (Basic/Profile) Test Strip Lots
What You Should Do
People With Diabetes: Discontinue use of these counterfeit test strips and call LifeScan for assistance. You should also contact your physician to assess potential treatment implications.
Telephone: U.S. 800 227-8862, (For all other countries, see Around the World).
E-mail: CustomerService@LifeScan.com
In addition, please file a report with FDA's MedWatch program or call 800 FDA-1088.
Health Care Professionals: Please share this information with your diabetes patients that use OneTouch Ultra and OneTouch (Basic/Profile) Test Strips. For additional information contact LifeScan.
Telephone: U.S. 800 227-8862, (For all other countries, see Around the World).
In addition, please file a report with FDA's MedWatch program or call 800 FDA-1088.
Pharmacies/Retailers: We recommend you routinely check your inventory of 50-Count OneTouch® Ultra® and OneTouch®(Basic®/Profile®) Test Strips. If you discover any counterfeit test strips please report your discovery immediately to LifeScan.
Telephone: U.S. 866 247-0264, (For all other countries, see Around the World).
In addition, please file a report with FDA's MedWatch program or call 800 FDA-1088.
Ask your patients that have received these counterfeit test strips to return them to you for verification and replacement, as necessary. Please be aware that LifeScan will not issue credit for counterfeit products. For restitution, you will need to contact your original source of supply for these test strips.
Counterfeit products are continually being modified to avoid detection. If you are purchasing any LifeScan products from a source that is not an authorized distributor, you may be placing your patients at risk of receiving counterfeit and secondary market products. Authorized distributors have agreed not to purchase products from the secondary market, which is a known source of counterfeit products.
See the most up-to-date list of Johnson & Johnson Healthcare Systems, Inc. authorized distributors (including Authorized LifeScan Distributors). 
We recommend you visit us online periodically for important Counterfeit Product Alerts or updates that may be issued in the future. If you require additional information, please contact LifeScan.
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