OneTouch® SureStep® Test Strips Recalled for Inaccurate Readings

LifeScan, Inc. is conducting a voluntary recall, in the United States, of eight lots of <"">OneTouch® SureStep® Test Strips, used by people with diabetes to measure blood glucose levels at home, the U.S. Food and Drug Administration (FDA) just announced. The OneTouch® SureStep® Test Strips are being recalled because they may provide falsely low glucose results when the glucose level exceeds 400 mg/dL.

The eight lots and sizes of consumer OneTouch SureStep Test Strips being recalled follow. Lot numbers appear on the outer carton and the test strip vial. 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:

• OneTouch SureStep 100-count size, lot numbers 2969251, 2969798, 2982369, and 2983467.

• OneTouch Sure Step 50-count size, lot numbers 2969795 and 2982566.

• Medicare/Mail Order 50-count size, lot numbers 2969481 and 2998193.

Patients with OneTouch® SureStep® Test Strips from the recalled lots are asked to call LifeScan, toll-free, at 1-800-574-6139 between 5:00 am and 7:00 pm Pacific Time, seven days a week or at the firm’s Website at to request replacement product. Replacement product will be shipped immediately and provided free of charge.

While waiting for replacements, the FDA is advising patients that 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 the recalled 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 significantly higher.

No injuries associated with these recalled test strips have been reported; however, if patients use the falsely low test results to determine their insulin dose, they may give themselves too little insulin, which could result in poor blood glucose control. Patients with high blood glucose may or may not have certain symptoms including increased thirst, frequent urination, headaches, difficulty with concentration, blurred vision, and fatigue (weak, tired feeling). High blood glucose must be recognized and treated promptly to avoid serious complications, such as coma and death, said the FDA.

Hospitals, clinics, and other multi-patient facilities using SureStep®Pro®, SureStep®Flexx®, or OneTouch® SureStep® Hospital Systems have also been notified of this issue. 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 400 mg/dL. LifeScan has advised these facilities of the appropriate actions to take in order to continue to use these SureStepPro Test Strips; however, healthcare facilities with access to alternative means of testing should consider temporarily discontinuing their use of their SureStep Systems until replacement test strips are available.

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