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FDA Orders Recall of LifeScan SureStep Meter

On July 28, 1998, the Food and Drug Administration asked LifeScan to recall older SureStep blood glucose meters which have a software problem that causes the meters to report an error condition ("Er 1") when it should report very high ("Hi", or more than 500 mg/dl). The recall is considered a Class I recall, which means that there is a reasonable probability that use of the product will cause adverse health consequences or death. The FDA received reports of two deaths associated with use of SureStep meters with this problem.

Users of the SureStep meter should check their meter's serial number to determine if it has the incorrect software. Meters with serial numbers that begin with L6000 through L7205, and meters with serial numbers L7206-GA-00001 through L7206-GA-01128 should contact LifeScan's 24-hour customer service line at 1-800-951-7226 to arrange for replacement or another LifeScan meter.

For Additional Information

• Recall Notice at the FDA Web Site
• Story from DIABETES.COM
• FDA Warns, Lifescan Glucose Meter Malfunction Could Be Fatal

Posted 1 August 1998

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Last Updated: Thursday August 29, 2002 20:59:48
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