LifeScan Recalls Specific Lots of Consumer and Professional OneTouch(R) SureStep(R) Test Strips Due To Inaccurate Readings at High Levels

While waiting for replacement product to arrive, it is important that patients with recalled test strips continue to test their blood glucose.  Patients with access to a meter that does not use OneTouch SureStep Test Strips should use this other meter to test their blood glucose until replacement product from LifeScan arrives.  If an alternate meter is not available, patients may continue to test using the recalled OneTouch SureStep Test Strips.  However, if patients obtain results above 400 mg/dL, they should contact their healthcare professional for further instructions because their glucose may be significantly higher.

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 available.

This field action is limited to eight lots of OneTouch SureStep Test Strips sold for consumer use in the U.S., and select SureStepPro Test Strips used in healthcare facilities. Similar recall actions are being taken in other countries where the affected product was distributed.

In 2006 LifeScan stopped selling OneTouch SureStep Meters in the U.S. but continued to provide test strips.  Today, OneTouch SureStep Meter users represent a very small portion of LifeScan's total customer base.  The vast majority of LifeScan's customers now use OneTouch® Ultra® Brand Meters, which use an entirely different technology.

LifeScan, Inc. is a leading maker of blood glucose monitoring systems for people with diabetes. For information about diabetes care and LifeScan products and services, visit www.OneTouchDiabetes.com.