Press Releases

	Illegally Relabeled/Repackaged OneTouch® Ultra® Test Strips Discovered in United States

May 13, 2008

If you use, recommend, distribute or sell OneTouch® Brand Test Strips, we want to make you aware that LifeScan has discovered illegally relabeled/repackaged OneTouch® Ultra® Test Strips in the United States. We have informed the Food and Drug Administration (FDA) of this issue and are supporting their efforts to remove this product from the marketplace. LifeScan is vigorously pursuing legal and other actions to address the situation.

Although the test strips were originally manufactured by LifeScan and were originally labeled for and distributed outside the United States, these products were subsequently intercepted, removed from their original cartons, and illegally relabeled and repackaged by third parties. In some cases, key performance information was altered (changed control solution range and/or changed product expiration date). These products were then illegally imported for resale in the United States by a number of unauthorized distributors.

The illegally relabeled/repackaged test strips represent a very small percentage of all OneTouch Ultra Test Strips in the marketplace. The risk of receiving illegally relabeled/repackaged test strips is greatly reduced if OneTouch Ultra Test Strips are purchased from pharmacies/retailers who secure their products from authorized LifeScan distributors.

LifeScan cannot assure the quality, accuracy and reliability of blood glucose test results obtained from relabeled test strips. Use of these illegally relabeled/repackaged test strips should be discontinued and they should be replaced immediately.

The lots of illegally relabeled/repackaged test strips that are subject to this notice can be identified by looking at specific characteristics of the lots involved such as their expiration date, control solution range and calibration code.

Current Alerts: Illegally Relabeled/Repackaged Products

Archive Of Past Alerts: Illegally Relabeled/Repackaged Products

People With Diabetes: Check your OneTouch Ultra Test Strips to verify that they are not illegally relabeled/repackaged test strips. If you determine you have illegally relabeled/repackaged One Touch Ultra Test Strips, discontinue their use immediately and secure replacement test strips from a pharmacy as quickly as possible so that you can continue testing as recommended by your healthcare professional. You should also contact your healthcare professional to inform them of this matter and discuss potential treatment implications.

You are encouraged to confirm that the pharmacy is purchasing OneTouch Ultra Test Strips directly from LifeScan or an authorized LifeScan distributor.

We also ask that you file reports with LifeScan by calling 877 903-0872 and the FDA by visiting www.FDA.gov/CDRH/MDR/MDR-Forms.html. Your reports will help in the ongoing investigation into the parties responsible for these illegally relabeled/repackaged products. We recommend you periodically visit this Web page or bookmark www.GenuineOneTouch.com for updates on this issue.

If your OneTouch Ultra Test Strips are not among the identified lots, you should continue to test your blood glucose with confidence when following their labeled instructions for use.

Healthcare Professionals: Please share this information with your diabetes patients who use OneTouch Ultra Test Strips by recommending they visit www.GenuineOneTouch.com for more information.

We advise you to routinely check any OneTouch Ultra Test Strips in your office for the presence of illegally relabeled/repackaged products. If you identify illegally relabeled/repackaged product, please call LifeScan at 866 679-9251 for disposition instructions and report your finding to the FDA by visiting www.FDA.gov/CDRH/MDR/MDR-Forms.html. Your report will help in the ongoing investigation into the parties responsible for these illegally relabeled/repackaged products. We recommend you periodically visit this Web page or bookmark www.GenuineOneTouch.com for updates on this issue.

Please be aware that LifeScan will not issue credit for illegally relabeled test strips. For restitution, you will need to contact your original source of supply for these products.

This action is limited to the lots of illegally relabeled/repackaged test strips identified in this notice. OneTouch Ultra Test Strips not among the lots that have been identified can be used with confidence when following their labeled instructions for use.

Pharmacies/Retailers : Immediately check your inventory for the presence of illegally relabeled/repackaged OneTouch Ultra Test Strips. If you identify illegally relabeled/repackaged product, please quarantine it and call LifeScan at 877 903-0872 for disposition instructions. Please be aware that LifeScan will not issue credit for illegally relabeled/repackaged test strips. For restitution, you will need to contact your original source of supply for these products.

We also ask that you report your finding to the FDA www.FDA.gov/CDRH/MDR/MDR-Forms.html. Your report will help in the ongoing investigation into the parties responsible for these illegally relabeled/repackaged products. We recommend you regularly check your inventory for illegally relabeled/repackaged OneTouch Ultra Test Strips.

Please share this information with your diabetes patients who use OneTouch Ultra Test Strips by recommending they visit www.GenuineOneTouch.com for more information.

This action is limited to the lots of illegally relabeled/repackaged test strips identified in this notice. You may continue to sell OneTouch Ultra Test Strips not among the illegally relabeled/repackaged lots that have been identified.

If you purchase any LifeScan products from a source that is not an authorized distributor, you may be at risk of receiving counterfeit and illegally relabeled/repackaged products. Authorized distributors have agreed not to purchase products from the secondary market, which is a known source of counterfeit and/or illegally relabeled/repackaged products. We recommend you periodically visit this Web page for updates on this issue.

See list of authorized LifeScan distributors of OneTouch® Products.