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U.S. Department of Health and Human Services

Safety

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LifeScan, Inc. OneTouch Ultra, InDuo and OneTouch FastTake Blood Glucose Meters

Audience: Healthcare professionals and consumers

LifeScan, Inc, initiated a worldwide notification to all users of its OneTouch Ultra, InDuo and OneTouch FastTake Meters. LifeScan found that it was possible for consumers, in the course of setting their meter's date and time, to accidentally change the unit of measure and thereby misinterpret their blood glucose results. The notification program includes letters to registered users and health care professionals, and also special instructions inserted in each package of test strips. The products are distributed worldwide primarily through retail pharmacy and mail order channels.

[May 17, 2005 - Recall Notice - FDA]
[May 10, 2005 - Press Release - LifeScan, Inc]