November 21, 2005
If you use, recommend, distribute or sell OneTouch® Ultra® Test Strips, we want to make you aware that LifeScan is voluntarily removing and offering replacement for the following one lot of 100-count OneTouch Ultra Blood Glucose Test Strips distributed in the United States.
100-Count OneTouch Ultra Test Strips
Note: Only this one lot of OneTouch Ultra Test Strips distributed in the U.S. is covered by this notice. No other OneTouch® Products are included in this replacement program.
LifeScan is replacing this lot of OneTouch Ultra Test Strips because the company has learned that a very small number of vials in this lot may contain strips that may not draw in a sufficient blood sample during testing, which can result in inaccurately low blood glucose test results. The U.S. Food and Drug Administration has been informed of this action.
Please compare 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 bottle. If you do not have OneTouch Ultra Test Strip Lot 2528640, your test strips are not subject to this recall.
How To Return Affected Product and Receive Replacement Test Strips
If you have any OneTouch Ultra Test Strips from Lot 2528640, please contact LifeScan for directions on how to return the affected test strips and to receive replacement bottles of test strips at no charge.
Customers should not test with OneTouch Ultra Test Strips from Lot 2528640 while they are waiting for their replacements. If required, replacement test strips will be provided to them.
If at any time you determine or suspect that there is a problem with any of your OneTouch® Brand products, please contact LifeScan for immediate assistance.
How To Contact LifeScan
People with diabetes
Telephone: U.S. (800) 717-0276
Telephone: U.S. (866) 461-0043
Telephone: U.S. (800) 600-7226