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Urgent Product Recall: Two lots of OneTouch Ultra Test Strips

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January 30, 2006

If you use, recommend, distribute or sell OneTouch® Ultra® Test Strips, we want to make you aware that LifeScan is voluntarily removing and offering to replace OneTouch Ultra Blood Glucose Test Strips in 100-count packages with a lot number of 2609684 and those in 50-count packages with a lot number of 2600318. LifeScan is replacing these two lots of OneTouch Ultra Test Strips because they did not undergo all of our manufacturing release steps.

Other than not completing these prescribed steps, the test strips in these two lots passed all performance requirements, and should not pose any harm to people testing with them. Nevertheless, LifeScan is asking customers to return product from Lots 2609684 and 2600318 and requesting users not to test any further with remaining strips from these two lots. LifeScan will provide replacement product.


How To Identify OneTouch Ultra Test Strips From The Affected Lots
Only OneTouch Ultra Test Strips from two lots are eligible for return and replacement:

Affected Lot Number

Number Description

2609684

100-Count OneTouch Ultra Test Strips

2600318

50-Count OneTouch Ultra Test Strips


Note: These are the only two lots of OneTouch Ultra Test Strips affected by this notice. No other OneTouch Products are included in this replacement program.

Please check the lot numbers of any OneTouch Ultra Test Strips in your possession. The lot number appears on the outside of the test strip box and on the label of the test strip vial. If you do not have any OneTouch Ultra Test Strips from either lot 2609684 or lot 2600318, then your test strips are not subject to this recall.

How To Return the Affected Test Strips andReceive Replacement OneTouch Ultra Test Strips
If you have any OneTouch Ultra Test Strips from either lot 2609684 or lot 2600318, please call LifeScan Customer Service and tell the customer service representative how many vials of test strips you have that need to be returned and replaced. You should also tell the LifeScan representative if you have other test strips available to test with while you wait for replacement strips. The LifeScan representative will then arrange to have replacement test strips sent to you at no charge, and will also provide information on how to return your test strips and packaging from lots 2609684 and 2600318.

How To Contact LifeScan

People with diabetes
Telephone: U.S. 800 717-9079

E-mail: CustomerService@LifeScan.com

Web site: www.LifeScan.com

Healthcare Professionals
Telephone: U.S. 800 951-7613

Retailers/Distributors
Telephone: U.S. 800 600-7226

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