LifeScan, Inc., and the Food and Drug Administration (FDA) are notifying health care professionals and consumers of a recall involving eight lots of OneTouch SureStep Test Strips used by people with diabetes to measure their blood glucose levels at home. The test strips may give falsely low glucose results when the glucose level is higher than400 mg/dL.
The recall affects approximately 14,000 packages of the 50- and 100-count OneTouch SureStep Test Strips, which were distributed nationwide between August 1, 2009 and January 28, 2010, primarily to consumers and some health care facilities.
The recall covers the following lots:
# 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
While no injuries have been reported due to the recalled test strips, patients who use the strips to determine their dose of insulin based on a falsely low test result could become ill. Patients with high blood glucose may or may not have certain symptoms such as increased thirst, frequent urination, headaches, difficulty concentrating, blurred vision and fatigue. High blood glucose must be recognized and treated promptly to avoid serious complications such as coma and death.
Patients who have the recalled test strips in their possession are advised to continue to test their blood glucose. If patients have access to a meter that does not use OneTouch SureStep Test Strips, they should use this meter until a replacement product from LifeScan is arrives. If not, they should continue to use their OneTouch SureStep test strips, but are advised to contact their healthcare professional if they obtain a result greater than 400 mg/dL.