Health Recall by FDA: Lifescan Meter

On April 14, 2006, Lifescan, Inc. announced an Urgent Medical Device Recall of the OneTouch® SureStep® Meters due to a potential issue with the meter's display. Lifescan has indicated that only meters with serial numbers between L1352Rxxxx and L5438Rxxx are affected. This is an expansion of the number of specific meters that LifeScan will replace as first identified in the September 2005 recall.

The display is made up of a series of “segments” that are turned on and off in various combinations to form letters and numbers. Recently, Lifescan has found that OneTouch SureStep Meters with serial numbers between L3152Rxxxx and L5348Rxxx may have a higher-than-expected segment failure rate, which can cause certain letters or numbers in the meter’s display to appear incomplete or missing. If the meter’s display is failing, there is a possibility that it will present a test result or a calibration code that could be misinterpreted or be unrecognizable. Lifescan has decided to remove from the market all OneTouch SureStep Meters with the affected serial numbers.

For further information regarding this recall of OneTouch SureStep Meter, patients and physicians can contact Lifescan Customer Service Line immediately for 24-hour assistance toll-free at: 1-866-679-9248 or the U.S. Food and Drug Administration Drug Information Office at 1-301-827-4573 or toll-free at 1-888-INFO-FDA or by accessing their Web site at www.fda.gov.