Sign up for our complimentary
weekly e-journal

Main Newsletter
Mastery Series
Therapy Series
 
Bookmark and Share | Print Article | Press Releases Previous | All Articles This Week | Next
This article originally posted 25 February, 2010 and appeared in  Issue 510Safety and Error PreventionBG ControlMedical Devices

LifeScan Recalls Specific Lots of Consumer and Professional OneTouch(R) SureStep(R) Test Strips Due To Inaccurate Readings at High Levels

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.

Advertisement

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.

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.

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.

This field action is limited to eight lots of OneTouch SureStep Test Strips sold for consumer use in the U.S., and select SureStepPro Test Strips used in healthcare facilities. Similar recall actions are being taken in other countries where the affected product was distributed.

In 2006 LifeScan stopped selling OneTouch SureStep Meters in the U.S. but continued to provide test strips.  Today, OneTouch SureStep Meter users represent a very small portion of LifeScan's total customer base.  The vast majority of LifeScan's customers now use OneTouch® Ultra® Brand Meters, which use an entirely different technology.

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.com.

 

 

Advertisement


 

Bookmark and Share | Print | Category | Home

This article originally posted 25 February, 2010 and appeared in  Issue 510Safety and Error PreventionBG ControlMedical Devices

Past five issues: Issue 739 | GLP-1 Special Editions July 2014 | Diabetes Clinical Mastery Series Issue 198 | Issue 738 | Diabetes Clinical Mastery Series Issue 197 |

2014 Most Popular Articles:

U.S. FDA Approves Inhaled Insulin: What Medical Professionals Need to Know
Posted July 04, 2014
Newly Updated: Comprehensive List of Insulins
Posted June 30, 2014
Can Insulin Treatment Do More Harm Than Good for Older Type 2's?
Posted July 04, 2014
Too Much Medication for Elderly Diabetes Patients?
Posted July 11, 2014
Which Is Better for BG Control: Aerobic or Anaerobic Exercise?
Posted July 11, 2014
Association between Diabetic Foot Ulceration and Premature Death
Posted July 04, 2014
ADA: Another Inhaled Insulin Treatment for Type 1 and 2 Diabetes May Be Coming Soon
Posted June 26, 2014
One Possible Answer to Healing Chronic Diabetic Foot Ulcers
Posted July 04, 2014
Pluses and Minuses of Glucose Lowering for Older Diabetes Patients
Posted July 18, 2014
Effects of Diabetes and Obesity on Normal Flora
Posted July 04, 2014


Browse by Feature Writer & Article Category.
A. Lee Dellon, MD | Aaron I. Vinik, MD, PhD, FCP, MACP | Beverly Price | Charles W Martin, DD | Derek Lowe, PhD | Dr. Bernstein | Dr. Brian Jakes, Jr. | Dr. Fred Pescatore | Dr. Tom Burke, Ph.D | Eric S. Freedland | Evan D. Rosen | Ginger Kanzer-Lewis | Greg Milliger | Kristina Sandstedt | Laura Plunkett | Leonard Lipson, M.A. | Louis H. Philipson | Maria Emanuel Ryan, DDS, PhD | Marilyn Porter, RD, CDE | Melissa Diane Smith | Michael R. Cohen, RPh, MS, ScD, FASHP | Paul Chous, M.A., OD | Philip A. Wood PhD | R. Keith Campbell, Professor, B.Pharm, MBA, CDE | Sheri R. Colberg PhD | Sherri Shafer | Stanley Schwartz, MD, FACP, FACE | Steve Pohlit | Steven V. Edelman, M.D. | Timothy S. Hollingshead |
Cast Your Vote
Do you offer group education sessions in your practice?
CME/CE of the Week
Calorie Expenditure: Raising Your Clients' Awareness
Anne Daly, MS, RD, BC-ADM, CDE  
Category: Nutrition
CE Credits: 50



Search Articles On Diabetes In Control