Diabetes strips recalled by Abbott for faulty readings

Diabetes strips recalled by Abbott

A voluntary recall has been issued by Abbott Laboratories for about 359 million diabetes test strips used to measure blood sugar levels, the U.S. Food and Drug Administration announced on Wednesday. The FDA said that the diabetes strips can give inaccurately low blood readings because they do not absorb the right amount of blood. This may pose risks to diabetics since they may increase an already high blood sugar level. Abbott said in a statement that a routine quality check found that some batches of the strips did not absorb enough blood for a glucometer to register the right blood sugar level. The company advised patients not to use the strips and said that it would replace them at no cost. The diabetes strips were manufactured from January to May and were sold to medical facilities and directly to consumers. "FDA and Abbott are reviewing the cause of the manufacturing defect to avoid this problem in the future," said the FDA's Office of In Vitro Diagnostics chief Alberto Gutierrez.

Abbott, based in North Chicago, Illinois, said that the affected brands include Precision Xtra, Precision Xceed Pro, Optium, OptiumEZ, Medisense Optium, and ReliOn Ultima. In its statement, Abbott clarified that although ReliOn Ultima strips are being recalled, the ReliOn Ultima blood glucose monitoring system itself is not subject to the recall. The batches or lots of diabetes strips that are affected by the recall were distributed in the United States and Puerto Rico only, said Greg Miley, the director of public affairs for Abbott Diabetes Care.

Posted by George Daniels on Saturday December 25 2010, 4:23 AM EDT. Ref: AP. All trademarks acknowledged. Filed under Featured News, Health. Comments and Trackbacks closed. Follow responses: RSS 2.0