OneTouch SureStep Test Strip Recall: May Provide Low Blood Glucose Levels

About 14,000 packages of OneTouch SureStep Test Strips, used to measure blood glucose levels in people with diabetes, have been recalled because they could provide incorrect information about blood glucose levels.

The glucose test strip recall was announced in late last week by the FDA and the manufacturer, Lifescan. The FDA warns that glucose blood levels above 400 mg/dL can cause the strips to give falsely low glucose results.

Although there have been no reported injuries in connection the defective OneTouch SureStep glucose test strips, patients who receive inaccurately low results may give themselves too low of an insulin dose. A low insulin dose can cause poor blood glucose control and could cause the patient to be unaware of dangerously high blood glucose levels. High blood glucose levels can lead to serious injury, coma and death.

Symptoms of high blood glucose levels can include thirst, frequent urination, headaches, problems concentrating, weakness and fatigue.

The recall affects eight lots of OneTouch SureStep Test Strips sold directly to consumers and some SurestepPro Test Strips sold to healthcare facilities. The recalled lots include 100-count OneTouch SureStep Test Strips with lot numbers 2969251, 2969798, 2982369 and 2983467; and 50-count OneTouch SureStep and Medicare/Mail Order strips with lot numbers 2969795, 2982566, 2969481 and 2998193.

The lot numbers are located on the outer carton and the test strip vial. The strips were distributed nationwide between August 1, 2009 and January 28, 2010.

Users who have test strips from the recalled lots should contact LifeScan to request replacement products free of charge. Consumers who have access to glucose testing meters that use different test strips should use those meters while waiting for replacements to arrive. If no other meters are available, consumers should continue to use the recalled test strips, but should contact their healthcare professional if they get a reading of 400 mg/dL, because their blood glucose levels may actually be much higher.

The company says it has contacted healthcare facilities who used the test strips in various meters and have informed them of the problem.