Urgent Field Safety Notice regarding One Touch® Ultra® Test Strips
April 2007
Dear LifeScan Customer,
LifeScan's overriding responsibility is to ensure the safety and well being of our meter users, consequently, our records show that you may use a LifeScan OneTouch® Blood Glucose Monitor that works with One Touch® Ultra® Test Strips.
A very small number of One Touch Ultra Test Strip containers (also called "vials") may contain a hole in the side (see photos below). This kind of damage to the vial can affect the test strips inside and lead to error messages or blood glucose results that are too high or too low.
The One Touch Ultra Test Strips are used with the OneTouch® Ultra®, OneTouch® Ultra2®, OneTouch® UltraEasy™ and OneTouch® UltraSmart® meters.
A closed test strip vial is designed to create a seal to keep out air and moisture. A test strip vial with a hole could allow air or moisture into the vial, which could harm the test strips.
This safety information only relates to OneTouch UltraTest Strips contained in a damaged vial (as pictured above). If there is no damage to the OneTouch Ultra Test Strip vial please continue to use the OneTouch UltraTest Strips as normal.
Do Not Use Test Strips From Damaged Vials of OneTouch Ultra
1) Inspect your OneTouch Ultra Test Strip vials for holes or other damage.
2) Do not use any test strips from vials that have a hole or any other damage.
3) Immediately report damaged vials to LifeScan Customer Care by calling us on freephone on 0800 028 8039 (Mon - Fri 8.30am - 6.00pm and Saturday 9.00am - 1.00pm). A Customer Care team representative will be available to help you and to send you replacement OneTouch Ultra Test Strips free of charge.
LifeScan takes this issue very seriously and has taken steps to prevent this problem in the future. The Medicines and Healthcare products Regulatory Agency (MHRA) has been notified of this issue and of the steps LifeScan has taken to solve it. We apologize for any inconvenience should you experience a damaged vial.
If you have any questions about your OneTouch Ultra Test Strips, please call LifeScan Customer Care on freephone 0800 028 8039. Thank you for your continued support of LifeScan.
Yours Sincerely,
Liz Prior
Customer Care Director