January 22, 2003

If you use or distribute SureStep®Pro Blood Glucose Test Strips, this letter is to inform you that LifeScan is recalling specific lots of SureStepPro 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 SureStepPro Test Strips in your possession with this 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.

Description of Off-Center Confirmation Dot Problem
A limited number of SureStepPro Test Strips within identified lots have "Confirmation Dots" that are off-center or split in half (see diagrams). Test strips with this problem may give inaccurately 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. 

How To Receive Replacement OneTouch SureStep Test Strips
Hospitals/Healthcare Facilities:

If you have any SureStepPro Test Strips from the List of Recalled Lot Numbers, call LifeScan and tell the customer service representative how much inventory you have that is subject to recall. LifeScan will send you an equivalent inventory of replacement product at no charge. At this time (if you purchase directly from LifeScan) you may also choose to increase your order quantity to ensure you have an adequate supply of tests strips from a single lot. While you wait for your replacement test strips to arrive, please do not distribute or use the SureStepPro Test Strips from the affected lots. Wherever possible, your replacement SureStepPro Test Strips should arrive within two business days after you contact LifeScan.

We recommend that you print this notice and keep it with your SureStep Brand System's instructional materials and that your healthcare practitioners 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 in this notice, 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 SureStep Brand Meter or Test Strips, please call LifeScan Customer Service for immediate assistance.

Distributors:

1. Locate and sequester any inventory of recalled SureStepPro Test Strips that you have.
2. Request all recalled inventory of SureStepPro Test Strips from your Hospital customers per your normal return procedures within 90 days.
3. Once you have received all returns of recalled product, call LifeScan for product return and replacement instructions.
4. When LifeScan receives your returned product we will issue a credit memo for an amount equivalent to your invoiced price of the recalled and withdrawn returned product. No deductions will be allowed.
   

Note: Only SureStepPro Test Strips from the lot numbers listed in this notice are subject to this action. Please do not return, on the basis of this notice, any product not listed without prior authorization from LifeScan.

Additional Lots Of SureStepPro Test Strips To Be Withdrawn From U.S. Distribution
As part of an ongoing investigation of the off-center confirmation dot problem, LifeScan is examining additional lots of SureStepPro Test Strips that were distributed in the United States to determine if they contain this problem. To date there have been no reports of this problem occurring in these lots. In support of this investigation, LifeScan is requesting only U.S. distributors return to LifeScan all product inventory from these lots. Contact LifeScan for more information about these specific lots that were distributed in the United States.

How To Contact LifeScan
If you need to contact LifeScan regarding this or any other 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 SureStepPro Test Strips

Recalled SureStepPro Test Strips Because Of Off-Center Confirmation Dots

Recalled SureStepPro Test Strips Because of Improperly Sealed Bottle Caps

Date Posted: January 22, 2003

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