News

Urgent Medical Device Recall: Confirm OneTouch® Ultra® Meter Unit of Measure

Back

January 20, 2006

If you use, recommend, distribute or sell OneTouch® Ultra® Blood Glucose Meters, we want to make you aware of an issue:

Beginning on April 18, 2005, OneTouch Ultra Meters were redesigned to not allow users to change the unit of measure setting. In the U.S., these meters were set to the mg/dL unit of measure. However, due to a manufacturing issue, an extremely small number of these meters do allow users to change their unit of measure setting between mg/dL and mmol/L.

When setting the date and time on such meters, it is possible for the user to accidentally change the unit of measure. If a meter is set to the wrong unit of measure, the user could misunderstand his or her blood glucose results.

What You Should Do
If you use a OneTouch Ultra Meter, it is important for you to call LifeScan Customer Service, even if you think that this manufacturing issue does not affect your meter. When you call, we can help you check and determine whether or not your meter is affected. If we find that your meter allows you to change the unit of measure, we will arrange to replace it.

Until you receive your replacement, you should continue to test your blood glucose with your current OneTouch Ultra Meter. There is no issue with the accuracy of the meter. Always check the unit of measure each time you test to make sure it is set to "mg/dL."

How To Contact LifeScan

People with diabetes
Telephone: U.S. 800 717-0291
(For all other countries, see Around the World)

E-mail: CustomerService@LifeScan.com

Web site: www.LifeScan.com

Healthcare Professionals
Telephone: U.S. 800 717-0293
(For all other countries, see Around the World)

Retailers/Distributors
Telephone: U.S. 800 600-7226
(For all other countries, see Around the World)

Back