More Than 300 Million Abbott Diabetes Care Products Recalled

HARTFORD — The Department of Consumer Protection is alerting consumers to new information from the US Food and Drug Administration (FDA) about certain blood glucose test strips used in the treatment of diabetes.

Abbott Diabetes Care announced that it has initiated a recall of 359 lots (approximately 359 million strips) of Precision Xtra, Precision Xceed Pro, MediSense Optium, Optium, OptiumEZ and ReliOn Ultima Blood Glucose Test Strips in the United States and Puerto Rico.

The test strips 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 and customers can continue to use the blood glucose monitors.

The affected test strips may give falsely low blood glucose results, which can lead users to try to raise their blood glucose when it is unnecessary and to fail to treat elevated blood glucose due to a falsely low reading. The problem appears to be related to longer than expected blood fill times. This may be dependent on the age of the strips and if the strips have been stored in (or exposed to) higher temperatures (above 72 degrees and not to exceed 86 degrees) for an extended period of time.

Customers who have test strips from these affected lots should discontinue use of the product. Abbott Diabetes Care will replace affected test strips at no charge. Abbott Diabetes Care initiated this recall following a routine internal quality review that indicated certain lots of Precision Xtra, Precision Xceed Pro, MediSense Optium, Optium, OptiumEZ and ReliOn Ultima blood glucose test strips may experience longer than normal blood fill times, which may cause falsely low blood glucose readings.

Customers are advised to contact their health care provider to determine testing options if they do not have any unaffected test strips to use.

Customers can check if they have test strips from the affected lots by visiting www.precisionoptiuminfo.com and looking up their product lot number.

Precision Xtra, Precision Xceed Pro, MediSense Optium, Optium, OptiumEZ, and ReliOn Ultima customers can also get information by calling Abbott Diabetes Care customer service at 800-448-5234 (English) and 800-709-7010 (Español).