Supplier News Breaks Archives
Abbott Diabetes Care recalls blood glucose test strips
December 23rd, 2010
ALAMEDA, Calif. – Abbott Diabetes Care has begun a recall of 359 lots of various brands of blood glucose test strips in the United States and Puerto Rico.
Working with the Food and Drug Administration, Abbott said that the recall involves approximately 359 million glucose test strips under the names Precision Xtra, Precision Xceed Pro, MediSense Optium, Optium, OptiumEZ and ReliOn Ultima.
The affected test strips may give falsely low blood glucose results, according to Abbott, which noted such readings could lead users to try to raise their blood glucose when it is unnecessary or fail to treat elevated blood glucose.
Abbott said it initiated the recall after a routine internal quality review. The company explained that the problem appears to be related to longer-than-expected blood fill times, which may depend on the age of the strips and if the strips have been stored in (or exposed to) higher temperatures (above 72˚F and not to exceed 86˚F) for an extended period of time.
The test strips being recalled are used with Abbott's Precision Xtra, Precision Xceed Pro, MediSense Optium, Optium and OptiumEZ blood glucose monitoring systems. ReliOn Ultima test strips are used with the ReliOn Ultima blood glucose monitoring system. The blood glucose monitors are not being recalled.
Abbott Diabetes Care has posted a list of the affected strips as of Dec. 22 on its web site. The company said customers who have test strips from these affected lots should discontinue use of the product, and Abbott will replace those strips at no charge.