On February 26, 2010, the Food and Drug Administration (FDA) and LifeScan announced a voluntary recall of eight lots (approximately 14,000 packages) of OneTouch SureStep Test Strips. The OneTouch test strips, used by diabetic patients to check blood glucose levels at home, were found to provide falsely low glucose results when glucose level is higher than 400 mg/dL.
If patients use the falsely low test results to determine their insulin dose, too little insulin may be administered, which could lead to thirst, frequent urination, difficulty concentrating, headaches, blurred vision, fatigue, coma, and even death.
The recall affects eight lots of OneTouch SureStep Test Strips with the following lot numbers:
The test strips were distributed nationwide between August 1, 2009 and January 28, 2010 and used in hospitals and clinics with the SureStepPro, SureStepFlexx, and OneTouch SureStep Hospital Systems.
Patients with recalled test strips are advised to use a separate glucose meter that does not require OneTouch SureStep Test Strips and call LifeScan at 800-574-6139 to request a free replacement product.