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Wednesday, December 29, 2010

Recall of Defective Glucose Test Strips

Diabetes Health Center

Recall of Defective Glucose Test Strips

FDA Says Faulty Strips Could Give Diabetes Patients Inaccurate Reading of Glucose Levels

By Bill Hendrick
WebMD Health News

Dec. 22, 2010 -- The FDA says it is working with Abbott Diabetes Care to recall 359 million defective glucose test strips -- sold under a variety of brand names -- that may make blood glucose levels look lower than they really are.

The FDA says the defective strips “can lead users to try to raise their blood glucose when it is unnecessary or to fail to treat elevated blood glucose due to a falsely low reading,” and that “both scenarios pose health risks.”

About 24 million Americans have diabetes.

Abbott says the defective strips aren’t absorbing enough blood to provide an accurate reading. The company also says test strips stored for a long time in medicine cabinets or test strips that have been exposed to warm temperatures could give false results.

“FDA and Abbott are reviewing the cause of the manufacturing defect to avoid this problem in the future,” Alberto Gutierrez, PhD, of FDA’s Center for Devices and Radiological Health, says in a news release.

Gutierrez says diabetes patients “should be aware of the recalled glucose test strips and take steps to prevent them from affecting their health.”

Slideshow: Blood Sugar Control and Insulin

Which Strips Are Being Recalled

The strips being recalled are used with Abbott’s MediSense Optium, Precision Xceed Pro, Precision Xtra, Optium, Optium EZ, and ReliOn Ultima blood glucose monitoring systems.

The lots were manufactured between January and May of this year and sold in retail stores in the U.S. and Puerto Rico. The strips are used both by consumers and health care professionals.

Abbott says the strips should not be used and will be replaced at no cost to consumers.

It says the monitoring systems themselves are not being recalled, just the defective strips.

Patients should contact their health care providers to determine testing options if they don’t have any unaffected test strips to use.

The FDA says it is working with Abbott to avoid any potential shortages of useable products. The company says it will take about eight weeks to produce and distribute enough strips to replace all the defective ones that have been distributed.

The FDA also says people with diabetes who want to find out if they have products that need to be returned should call Abbott Diabetes Care at 800-448-5234 for English speakers and at 800-709-7010 for Spanish speakers. The FDA says people wishing to look up test strip lot numbers should visit the web site www.precisionoptiuminfo.com.

In addition, consumers should report serious adverse side effects to the FDA by phone at 800-332-1088, fax at 800-FDA-0178, online at www.fda.govMedWatch/report.htm, or via regular mail at www.fda.gov/MedWatc/getforms.htm, where pre-addressed forms may be obtained.