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Abbott Issues Nationwide Urgent Medical Device Correction for Blood Glucose Mete

Abbott Diabetes Care, a division of Abbott Laboratories , said late Friday that it has voluntarily initiated a correction and notification to users of its blood glucose meters in the U.S. Abbott’s blood glucose meters are designed to allow patients to display one of two standard units of measure: milligrams per deciliter, the U.S. standard, or millimoles per liter, a standard commonly used in other countries.

Abbott Issues Nationwide Urgent Medical Device Correction for Blood Glucose Meters

Abbott Diabetes Care, a division of Abbott Laboratories , said late Friday that it has voluntarily initiated a correction and notification to users of its blood glucose meters in the U.S. Abbott’s blood glucose meters are designed to allow patients to display one of two standard units of measure: milligrams per deciliter, the U.S. standard, or millimoles per liter, a standard commonly used in other countries. Abbott has received consumer complaints that in the course of setting the time and date for their meters, users have inadvertently changed the units of measure from milligrams per deciliter to millimoles per liter, leading to the possible misinterpretation of test results. Abbott Diabetes Care has filed 17 medical device reports in the U.S. associated with this issue based on a U.S. user base of 2.25 million. Abbott said it is working with the Food and Drug Administration to execute the voluntary medical device correction.

The products are sold under several model names in the United States including FreeStyle(R), FreeStyle Flash(TM), FreeStyle Tracker(TM), Precision Xtra(TM), MediSense(R) Sof-Tact(TM), and MediSense(R) Optium(TM). Private label brands include ReliOn(R) Ultima, Rite Aid(R) and Kroger(R) blood glucose meters. Test strips are not affected by this correction.

Consumers using Abbott Diabetes Care blood glucose meters may continue to safely use their meters and should verify that their meter is displaying the correct unit of measure each time they test. Consumers with questions may call Abbott Diabetes Care customer care at 1-800-553-4105.