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FDA announces glucose test strips recall
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The FDA announced that it is working with Abbott Diabetes Care to recall 359 different lots of glucose test strips because of their inability to absorb enough blood for monitoring and the potential for providing falsely low blood glucose readings.
Brands affected by the recall include:
- Precision Xceed Pro;
- Precision Xtra;
- Medisense Optium;
- Optium;
- OptiumEZ; and
- ReliOn Ultima.
The test strips were manufactured between January and September 2010 and are available directly to consumers in retail and online settings, although they are also used in health care facilities.
The recall is restricted to certain lots of test strips distributed in the United States and Puerto Rico. Other Abbott Diabetes Care products, including blood glucose monitoring systems, are not affected by the recall.
“Patients with diabetes should be aware of the recalled glucose test strips and take steps to prevent them from affecting their health,” Alberto Gutierrez, PhD, director for the Office of In Vitro Diagnostics in the FDA’s Center for Devices and Radiological Health, said in a press release. “FDA and Abbott are reviewing the cause of the manufacturing defect to avoid this problem in the future.”
The FDA has provided recommendations for consumers and health care professionals on the agency’s Web site that explain how to determine whether a particular lot is affected, how to order free replacement strips and how to use recalled strips to reduce the likelihood of a false result.
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