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U.S. Department of Health and Human Services

Medical Devices

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LifeScan, Inc. Blood Glucose Meters

Class 1 Recall
Date Recall
Initiated

April 11, 2005

Product:

LifeScan blood glucose meters: OneTouch® Ultra®, InDuo® and OneTouch® FastTake®. The products are distributed primarily through retail pharmacy and mail order channels. Distribution of the products is worldwide with 6 million meters being distributed including 2.6 million in the United States (1.8 million registered users).

Shipments of test strips for these products are not affected.

Use:

Blood glucose meters are used by diabetes patients to measure the amount of glucose in their blood, and as an aid to monitor the effectiveness of diabetes management in the home or clinical setting.

Recalling Firm:

LifeScan, Inc.
1000 Gibraltar Drive
Milpitas, California 95035-6301

Reason for Recall:

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.

Incorrect measurement settings may result in users misinterpreting their blood glucose results. All three affected meter systems were originally designed to allow patients to select one of two standard 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.

Patients with affected glucose meters are advised to contact LifeScan, Inc., to confirm their meter is set to the proper unit of measure.

Public Contact:

Consumers may contact LifeScan Customer Service at 1-800-515-0915.

FDA District:

San Francisco

FDA Comment:

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.

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.

Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of the product will cause serious injury or death.

  For additional information on this product recall, see the nearby links.