December 22nd, 2010
05:08 PM ET

Glucose test strips recalled

Abbott Diabetes Care is voluntarily recalling 359 million glucose test strips because they may be defective and cause false low blood glucose readings, the Food and Drug Administration (FDA) announced Wednesday.

The strips don't absorb enough blood for proper monitoring, the agency says. The strips are sold in the United States and in Puerto Rico.

The strips are marketed under the brand names Precision Xceed Pro; Precision Xtra; MediSense Optium; Optium; OptiumEZ and ReliOn Ultima, and are used with Abbott blood glucose monitoring systems bearing the same name. The monitoring systems are not being recalled.

The false readings can cause patients to try to raise their blood sugar needlessly, or not treat elevated levels because of low reading that are false.

"Patients with diabetes should be aware of the recalled glucose test strips and take steps to prevent them from affecting their health," said Alberto Gutierrez, Ph.D., director for the Office of In Vitro Diagnostics in FDA's Center for Devices and Radiological Health. "FDA and Abbott are reviewing the cause of the manufacturing defect to avoid this problem in the future."

The strips in question were manufactured between January and May of this year and sold in stores and online.  They were used in hospitals and other health care facilities.  Abbott says the problem may be the age of the strips and how they were stored–in particular,  exposure to high temperatures for extended periods of time may be a contributing factor.  The company voluntarily started the recall after a "routine internal quality review" found the problem.  So far they've reported 22 safety reports to the FDA.

"Abbott is committed to the highest quality standards and is taking action to address and prevent this issue from recurring," Greg Miley, an Abbott Diabetes Care spokesman, said. In the meantime, Abbott will replace the affected strips at no charge.  The lot numbers, along with recall information for both consumers and health care providers can be found at www.precisionoptiuminfo.com.

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