November 24, 2008

At LifeScan, we hold our products to the highest standards of quality; constantly working to ensure they provide glucose results you can rely on. For that reason, we're also committed to communicating with you when we learn of product that may not be performing to our expected standards.

If you use, recommend, distribute or sell OneTouch® SureStep® Test Strips, this notice is to advise you that LifeScan is voluntarily removing and offering to replace free of charge two specific lots of OneTouch® SureStep® Blood Glucose Test Strips sold in the United States. We are replacing these two lots because we have learned that a very small number of vials in these lots may contain test strips that could produce inaccurately low or no blood glucose test results.

We have also informed the U.S. Food and Drug Administration of this action.

How To Tell If Your OneTouch SureStep Test Strips Are Affected

Please compare the lot numbers of any OneTouch SureStep Test Strips in your possession with the two affected lot numbers listed below. The lot number appears on the outside of the test strip box and on the test strip vial label. If you do not have any test strips from either of these two lots, then your OneTouch SureStep Test Strips are not affected and no further action is required. Patients can continue to use them to test their blood glucose.

If you have any OneTouch SureStep Test Strips from either of the two lot numbers identified in this notice, please stop using/distributing them immediately and call LifeScan for assistance. The LifeScan representative will tell you how to return your affected test strips and will arrange to have replacement test strips sent to you at no charge. While you wait for your replacement test strips to arrive, please do not use/sell the OneTouch SureStep Test Strips with the lot numbers identified in this notice.

Please know that, at LifeScan, we continually strive to ensure that we provide you with product of the highest quality. We apologize for any inconvenience this issue may cause, and we thank you for your continued support of LifeScan.

How to Contact LifeScan

People with diabetes
Telephone: 1 800 951-7617

Health Care Professionals
Telephone: 1 866 621-6120

Pharmacies/Distributors
Telephone: 1 800 218-2748

Press Release Index

Home | Company | Products | Diabetes Care | OneTouch Gold | Professionals | Feedback | Around the World

The health information on this Web site is for general background purposes and is not a substitute for medical advice or treatment for specific conditions. Seek prompt medical attention for health care questions you have. Consult your physician before making changes to your medication, diet, fitness program, or blood glucose testing schedules.

This site is intended for visitors from the United States and published by LifeScan, Inc., which is solely responsible for its contents.
By using this site, you agree to our Legal Notice and Privacy Policy.
AdvaMed Guidelines.
© LifeScan, Inc. 1996-. All trademarks are the property of their respective owners.