FDA Recalls Abbott Diabetes Care Glucose Test Strips

The U.S. Food and Drug Administration (FDA) today announced that the agency is working with Abbott Diabetes Care to recall 359 different lots of glucose test strips marketed under the following brand names: • Precision Xceed Pro; • Precision Xtra; • Medisense Optium; • Optium; • OptiumEZ; and • ReliOn Ultima These strips are used with Abbott’s Precision Xtra, Precision Xceed Pro, MediSense Optium, Optium, Optium EZ and ReliOn Ultima blood glucose monitoring systems. As many as 359 million strips may be affected by the recall. The blood glucose monitoring systems are not affected by this recall. The test strips, which were manufactured between January and May 2010, are sold both in retail and online settings to consumers, but are also used in health care facilities. The test strips with lot numbers that have been recalled may give falsely low blood glucose results. False results may lead patients to try to raise their blood glucose when it is unnecessary, or they may fail to treat elevated blood glucose due to a false, low reading. Both scenarios pose risks to a patient’s health. FDA has provided specific recommendations for consumers and healthcare professionals with regard to the recalled products. These recommendations explain how to determine whether a particular lot is affected, how to order a free replacement set of strips, and how to use recalled strips to reduce the likelihood of a false result.
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm237900.htm