January 22, 2003

If you use, recommend or sell OneTouch®SureStep® Blood Glucose Meters and Test Strips (also sold in some countries under the GlucoTouch® Brand name), this letter is to inform you that LifeScan is recalling specific lots of OneTouch SureStep Blood Glucose Test Strips due to two distinct problems:

1. Off-Center Confirmation Dot – A limited number of OneTouch SureStep Test Strips have a problem causing the test strip’s “Confirmation Dot” to be off-center or split in half.  These test strips may give inaccurately low blood glucose test results or may produce repeated meter messages (such as flashing the “Remove Strip” icon, or displaying an Error 3) instead of a test result. 
2. Improperly Sealed Test Strip Bottle Cap – A small number of Test Strip bottles from some lots have a cap that may cause the test strip bottles to be sealed improperly.  Test strip bottles with an improperly sealed cap may not protect the test strips from environmental conditions and may give inaccurately low blood glucose test results.

Please compare the lot numbers of any OneTouch SureStep Test Strips in your possession with the List of Recalled Lot Numbers.  The lot number appears on the outside of the test strip carton and on the label of the test strip bottle.  If you do not have product from the lot numbers listed, your test strips are not subject to this recall.  The U.S. Food and Drug Administration has been informed of this action.

How To Receive Replacement OneTouch SureStep Test Strips
If you have any OneTouch SureStep Test Strips from List of Recalled Lot Numbers, call LifeScan and tell the customer service representative how many bottles of test strips you have that need replacement. Tell the representative if you have other test strips available to test with while you wait for replacement strips.  LifeScan will then send you replacement bottles of test strips at no charge.  If required, replacement test strips will be provided to you within two business days wherever possible.  While you wait for your replacement test strips to arrive, please do not use, sell or distribute the OneTouch SureStep Test Strips from the recalled lots.

Description of Off-Center Confirmation Dot Problem
A limited number of OneTouch SureStep Test Strips have a problem causing the test strip’s “Confirmation Dot” to be off-center or split in half (see diagrams).  These test strips may give inaccurately low blood glucose test results or may produce repeated meter messages (such as flashing the “Remove Strip” icon, or displaying an Error 3) instead of a test result. 

Other Recommendations
We recommend that you keep this letter with your OneTouch SureStep Owners Booklet and visually inspect each test strip prior to use. If you ever observe anything unusual about your test strips, such as unusual coloring of the test strip pad or off-center confirmation dots like those pictured above, the strip may be defective and should not be used.   If at any time you determine or suspect that there is a problem with your OneTouch SureStep Meter or Test Strips, please call LifeScan Customer Service for immediate assistance.  

How To Contact LifeScan
At LifeScan we know our customers rely on our products to help them manage their diabetes. It's a responsibility we take very seriously. If you need to contact LifeScan regarding this issue please contact us in one of the following ways:

People with diabetes
Telephone: U.S. 866 265-1805, for other countries, see Around the World.)

Healthcare Professionals
Telephone: U.S. 866 265-1805, for other countries, see Around the World.)

Retailers/Distributors:
Telephone: 866 756-7566, for other countries, see Around the World.)

Thank you for your continued support of LifeScan.

Recalled OneTouch SureStep Test Strips

Recalled OneTouch SureStep Test Strips Because Of Off-Center Confirmation Dots

Recalled OneTouch SureStep Test Strips Because of Improperly Sealed Bottle Caps

Date Posted: January 22, 2003

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