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U.S. Department of Health and Human Services

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Firm Safety Alert

FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.

LifeScan, Inc. Announces Worldwide Correction Concerning Certain Blood Glucose Meters

Contact:
LifeScan Customer Services
1-800-515-0915

FOR IMMEDIATE RELEASE -- LifeScan, Inc, a maker of blood glucose testing systems for people with diabetes, is initiating a worldwide notification to all users of its OneTouch® Ultra®, InDuo® and OneTouch® FastTake® Meters that it may be possible for users to misinterpret their blood glucose results. 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.

In the United States, milligrams per deciliter or "mg/dL" is the standard of measure for blood glucose testing systems. In many other countries, millimoles per liter or "mmol/L" is used.

From the beginning of 2004 through mid-March 2005, LifeScan, Inc., has received 40 worldwide reports of adverse events associated with these meters being set to the incorrect unit of measure. These events have generally consisted of temporary periods of high or low blood sugar, some of which required medical attention. An accidental change in the meter's unit of measure can contribute to people with diabetes misunderstanding their test results and managing their diet or medication in a way that can result in temporary periods of high or low blood sugar. There are an estimated 4.7 million users of these products worldwide.

To further address this issue, LifeScan, Inc., has temporarily stopped shipment of versions of the OneTouch® Ultra®, OneTouch® FastTake® and InDuo® Systems that allow users to change the unit of measure. LifeScan, Inc., is implementing a product modification for its new OneTouch® Ultra® Meters that will prevent users from inadvertently switching their meter's unit of measure. Shipments of the OneTouch® Ultra® Meters with this modification are expected to begin next week.

The timing to resume shipments of InDuo® and OneTouch® FastTake® Meters has not been determined. In some countries, the FastTake® Meter is sold under the EuroFlash®, SmartScan® and PocketScan® Brand names.

LifeScan, Inc., has notified the U.S. Food and Drug Administration (FDA) and other regulatory agencies around the world of this voluntary action.

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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