Glucose test strips under various brand names made by Abbott Diabetes Care are being recalled because the products are likely to report false low blood glucose results which pose serious health risks to consumers. The recall is ranked as a Class 1, the most serious type of recall the Food and Drug Administration (FDA) can give and is reserved for situations in which there is a potential for serious injury or death. 

The recall includes 359 different lots of glucose tests strips marketed under the following brand names: Precision Xceed Pro, Precision Xtra, Medisense Optium, Optium, OptiumEZ, and ReliOn Ultima.

The problem relates to a defect that inhibits sufficient absorption of blood into the test strip. Strips exposed to warm weather or prolonged storage may be more likely to provide a false result. The affected test strips may give falsely low blood glucose results, which can lead to patients to try to raise the blood glucose when it is unnecessary, or to fail to treat elevated blood glucose due to a falsely low reading. Both scenarios pose health risks.

The recalled test strips work 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 strips were manufactured between January and May 2010, and are sold in retail stores, online settings and in health care facilities.

The FDA has recommendations for consumers and health care professionals on the website www.Precisionoptiuminfo.com. These recommendations explain whether a particular lot is affected, how to order a free replacement set of strip, and what steps to take in the meantime.