LifeScan, a maker of blood glucose monitoring systems, is conducting a voluntary recall in the US of eight lots of OneTouch SureStep Test Strips, used by people with diabetes to measure their blood glucose levels at home. The test strips are being recalled because they may provide falsely low glucose results when the glucose level is higher than 400 mg/dL.
The eight lots of consumer OneTouch SureStep Test Strips being recalled are 2969251 100-ct OneTouch SureStep, 2969798 100-ct OneTouch SureStep, 2982369 100-ct OneTouch SureStep, 2983467 100-ct OneTouch SureStep, 2969795 50-ct OneTouch SureStep, 2982566 50-ct OneTouch SureStep, 2969481 50-ct Medicare/Mail Order, 2998193 50-ct Medicare/Mail Order
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 400mg/dl. LifeScan has advised these facilities of the appropriate actions to continue to use these SureStepPro Test Strips. No injuries associated with these recalled test strips have been reported.
Replacement product will be shipped immediately and provided free of charge. 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 higher, said the company.
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.