WEDNESDAY, Dec. 22 (HealthDay News) -- The U.S. Food and Drug Administration has notified health care professionals and consumers of a recall of 359 lots of Abbott Diabetes Care glucose test strips, as the test strips may give falsely low blood glucose results and negatively impact a patient's health.
The test strips being recalled are used with Abbott's Precision Xtra, Precision Xceed Pro, MediSense Optium, Optium, OptiumEZ, and ReliOn Ultima blood glucose monitoring systems. However, the monitoring systems are not being affected by the recall. The recall is related to the test strips' inability to absorb enough blood for monitoring, with test strips exposed to warm weather or prolonged storage more likely to be associated with a false result.
The potential for falsely low blood glucose results may lead patients to raise their blood glucose unnecessarily or fail to treat elevated blood glucose. The FDA recommends that health care providers immediately switch to using test strips from unaffected lots if they have test strips from affected lots. If test strips not affected by the recall are unavailable, practitioners should discontinue use of their blood glucose test system and use an alternate method. Practitioners should also verify any blood glucose test system results that do not match a patient's symptoms or seem unexpected. In addition, practitioners should use precautions to reduce the chance of an erroneous reading.
"Patients with diabetes should be aware of the recalled glucose test strips and take steps to prevent them from affecting their health," Alberto Gutierrez, Ph.D., director for the Office of In Vitro Diagnostics in the FDA's Center for Devices and Radiological Health, said in a statement. "FDA and Abbott are reviewing the cause of the manufacturing defect to avoid this problem in the future."
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