The FDA announced Abbott Laboratories have recalled 359 different lots of glucose test strips marketed under the brand names: Abbott’s Precision Xtra, Precision Xceed Pro, MediSense Optium, Optium, Optium EZ and ReliOn Ultima.
According to a statement released by Abbott Laboratories, "ReliOn Ultima test strips are used with the blood glucose monitoring system, of the same name. The blood glucose monitors are not being recalled and customers can continue to use them."
The U.S. Food and Drug Administration (FDA) report that as many as 359 million testing strips may be affected by the recall, which is limited to the glucose test strips that were distributed in the United States and Puerto Rico.
The prepared statement from the FDA said, "The test strips being recalled may give falsely low blood glucose results. False results may lead patients to try to raise their blood glucose unnecessarily, or they may fail to treat elevated blood glucose because of a false, low reading."
The recalled strips are unable to "absorb enough blood for monitoring." said the FDA.
Modern Healthcare reports shares of Abbott Laboratory stock fell in price by .10 cents after the recall was announced Wednesday.
The Illinois based Abbott, is offering to replace all the defective strips at no charge to the consumer and advises customers to immediately stop using them and return them to the place of purchase.
The Abbott announcement, added the test strips being recalled were manufactured from January to September 2010 and have been sold in both retail stores as well as online. Some are also being used in health-care facilities, as well in private homes.
According to the FDA, “Patients with diabetes should be aware of the recalled glucose test strips and take steps to prevent them from affecting their health,” said Alberto Gutierrez, Ph.D., director for the Office of In Vitro Diagnostics in FDA’s Center for Devices and Radiological Health. “FDA and Abbott are reviewing the cause of the manufacturing defect to avoid this problem in the future.”
Consumers can check affected lots by calling Abbott Diabetes Care customer service at 1-800-448-5234 (English) and 1-800-709-7010 (Español) or by visiting their website and looking up the product purchased by lot number.