Alerts and Advisories

Health Alerts > 3/1/10 LifeScan Recalls Specific Lots of Consumer and Professional OneTouch® SureStep® Test Strips Due To Inaccurate Readings at High Levels

FOR IMMEDIATE RELEASE -- MILPITAS, Calif., Feb. 24 /PRNewswire/ -- 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 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:

Recalled Lot

Size

Description

# 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


Lot #'s are located on the outer carton and test strip vial.

 

Patients with test strips from the recalled lots are asked to call LifeScan at 800 574-6139 between 5:00 am and 7:00 pm Pacific Time, seven days a week or visit www.SureStep.com to request replacement product. 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 significantly higher.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.

 

LifeScan, Inc. is a leading maker of blood glucose monitoring systems for people with diabetes. For information about diabetes care and LifeScan products and services, visit www.OneTouchDiabetes.com1.

 

CONTACT: David Detmers, LifeScan, Inc., +1-408-942-5955


Please feel free to call with any questions.       

Deb McMahan, MD.   

 


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