Safety Alerts & Recalls

What does this mean?

Measuring your blood glucose level is an important of part of managing your diabetes, especially if you use insulin. High blood glucose must be recognized and treated right away to avoid serious complications. Patients who use these recalled test strips may not be able to accurately recognize high blood glucose levels and may not manage their diabetes correctly.

If you have a blood glucose meter at home, please check your supply of test strips and see if they are OneTouch SureStep Test Strips and if they are labeled with one of the recalled lot numbers. Lot numbers are located on the outer carton and test strip vial. If you have test strips from the recalled lots please 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. If you have access to a meter that does not use OneTouch SureStep Test Strips, you should use this other meter to test your blood glucose until replacement product from LifeScan arrives. If an alternate meter is not available, you may continue to test your blood glucose using the recalled OneTouch SureStep Test Strips. However, if you obtain results above 400 mg/dL, you should contact your healthcare professional for further instructions because your glucose may be much higher than the reading. Symptoms of high blood glucose may include increased thirst, frequent urination, headaches, difficulty with concentration, blurred vision and fatigue (weak, tired feeling). If you have any of these symptoms, please contact your healthcare professional and seek medical attention right away.

LifeScan Recalls Eight Lots of OneTouch SureStep Test Strips Due To Falsely Low Readings

LifeScan, Inc. is conducting a 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. 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.

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

To view the FDA MedWatch Safety Alert: more information here

To view the Life Scan Press Release: more information here

Source: Manufacturer
Publication Date: 2010-03-01
Last Updated: 2010-03-01

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