Medical Devices

Users of Blood Glucose Meters Must Use Only the Test Strip Recommended For Use With Their Meter

Background:The US Food and Drug Administration, Abbott Diabetes Care, and LifeScan are aware of instances where incorrect results were obtained using LifeScan OneTouch® Ultra® test strips with Abbott Precision Xtra® meters. OneTouch® Ultra® test strips are not intended for use with Precision Xtra® meters, and doing so may lead to lower than expected blood glucose results. Similar problems can also occur if other brands and models of meters and strips are not used in proper combination.

It is important for users to understand that if they use a test strip that is not recommended for their meter, the device may fail to give results or may generate inaccurate results.

Recommendations:Users of blood glucose meters should carefully read the Owner’s Manual and only use the test strips that are specified for that meter. As an additional check, the test strip inserts identify the blood glucose meters with which they should be used.

Healthcare providers and pharmacists should advise their patients to use only test strips that are compatible with their meter.

    

Page Last Updated: 06/05/2014
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