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LifeScan Announces Worldwide Correction Concerning Certain Blood Glucose Meters

It may be possible for users to misinterpret their blood glucose results.

LifeScan, Inc, a maker of blood glucose testing systems is initiating a worldwide notification to all users of its OneTouch® Ultra®, InDuo® and OneTouch® FastTake® Meters

All three affected meter systems were originally designed to allow patients to select one of two units of measure to display their test results. This selection is typically determined by the standard used by the country in which they live. LifeScan, Inc., 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.

In addition, very rarely, an event such as dropping a meter while in use can cause a brief power loss, which may also unexpectedly change the unit of measure and/or the code number used to program the meter to match a particular vial of test strips.

The products are distributed worldwide primarily through retail pharmacy and mail order channels. Shipments of test strips for these systems are not affected.

Users should continue to test their blood glucose. LifeScan, Inc., is instructing patients to confirm their meter’s unit of measure and the code number each time they test.

The company is conducting a worldwide notification program consisting of letters to registered users and health care professionals, and also special instructions inserted in each package of test strips. Patients with these products are advised to contact LifeScan, Inc., to confirm their meter is set to the proper unit of measure. In the United States, patients can call LifeScan Customer Service at 1-800-515-0915. Contact information for other countries is available at http://www.LifeScan.com.

LifeScan, Inc., is a Johnson & Johnson company. For additional information and instructions on proper meter use, please visit www.LifeScan.com or, in the U.S., call LifeScan Customer Services at 1-800-515-0915.

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