ABBOTT ISSUES URGENT DEVICE CORRECTION
Abbott Diabetes Care has voluntarily initiated a correction and notification for its blood glucose meters in the U.S. after receiving consumer complaints that while setting the time and date for the devices, they have inadvertently changed the units of measure from milligrams per deciliter to millimoles per liter.
This change could lead to misinterpretation of test results, which could result in possible under-treatment and the potential for hyperglycemia, the company said. Abbott is advising users to make sure the device is displaying the correct unit of measure each time they test. The company is working with the FDA to execute this voluntary correction.
The products are sold under several model names in the U.S., including FreeStyle, FreeStyle Flash, FreeStyle Tracker, Precision Xtra, MediSense Sof-Tact, and MediSense Optium. Private label brands include ReliOn Ultima, Rite Aid and Kroger blood glucose meters. Test strips are not affected by this correction.