February 24, 2010

Frequently Asked Questions:

Are any other products affected by this voluntary removal?
This recall is limited to eight lots of OneTouch® SureStep® Test Strips sold for consumer use in the U.S.
No other LifeScan products, including SureStep®Pro® or OneTouch® Ultra® Test Strips, are being recalled.

Has the FDA been made aware of this issue?
Yes, the FDA has been made aware.

I am in possession of the affected lot number; however, I haven’t had any problems with them.  Can I keep using them?
It is important that you continue to test your blood glucose while you wait for replacement product to arrive.  However, if you use these affected strips and receive a result of 400 mg/dL or higher from your OneTouch® SureStep® System, there is a possibility that your blood glucose is significantly higher and you should confirm this result using a second meter that does not use the OneTouch SureStep Test Strips or contact your healthcare professional for further instructions.

How can people trust their blood glucose test results and not worry about a false reading?
At LifeScan we hold our products to the highest standards of quality; constantly working to ensure they provide glucose results you can rely on.  You can rest assured that if you do not have an affected test strip lot number that your OneTouch® SureStep® system is safe to use.  Please refer to your owner’s booklet for proper care and maintenance of your system. 

I heard LifeScan is no longer manufacturing the OneTouch SureStep meter.  Is this true?
In 2006 LifeScan stopped selling OneTouch® SureStep® Meters in the U.S. but continued to provide test strips. LifeScan is discontinuing the OneTouch® SureStep® consumer product line in the U.S.  This action is being taken because the demand for this test strip has declined and greater focus is being given to products that better meet patient needs by supporting standards of care.  The decision to discontinue the OneTouch® SureStep® consumer product line is not the result of any safety issues.

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