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LifeScan Recalls Specific Lots of Consumer and Professional OneTouch(R) SureStep(R) Test Strips Due To Inaccurate Readings at High Levels
Date:2/24/2010

>LifeScan estimates approximately fourteen thousand packages (50- and 100-count) of consumer OneTouch SureStep Test Strips were distributed nationwide between August 1, 2009 and January 28, 2010.

No injuries associated with these recalled test strips have been reported.  However, if patients use the falsely low test results to determine their insulin dose, they may give themselves too little insulin, which could result in poor blood glucose control.  Patients with high blood glucose may or may not have certain symptoms including increased thirst, frequent urination, headaches, difficulty with concentration, blurred vision and fatigue (weak, tired feeling).  High blood glucose must be recognized and treated promptly to avoid serious complications, such as coma and death.

Hospitals, clinics and other multi-patient facilities using SureStep®Pro®, SureStep®Flexx® or OneTouch® SureStep® Hospital Systems have also been notified of this issue.  All three of these systems use SureStep®Pro® Test Strips which also may provide inaccurately low test results when the blood glucose reading is greater than 400 mg/dL.  LifeScan has advised these facilities of the appropriate actions to take in order to continue to use these SureStepPro Test Strips.  However, healthcare facilities with access to alternative means of testing should consider temporarily discontinuing their use of their SureStep Systems until replacement test strips are avail
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SOURCE LifeScan, Inc.
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