Abbott Laboratories (NYSE:ABT) recalled 359 million blood glucose test strips comprised of six different products manufactured by its diabetes business.
Alameda, Calif.-based Abbott Diabetes Care pulled the Precision Xtra, Precision Xceed Pro, MediSense Optium, Optium, OptiumEZ and ReliOn Ultima test strips off the market in the U.S. and Puerto Rico because they may give falsely low readings, according to the company. The strips’ associated blood glucose monitor devices have no been recalled, Abbott said.
The falsely low blood glucose results "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 company said in prepare remarks. "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 72ºF and not to exceed 86ºF) for an extended period of time," the company said.
The test strips were manufactured between January and Sept. 2010 and are sold both in retail and online settings directly to consumers, but are also used in healthcare facilities, according to the Food & Drug Administration.
The watchdog agency recommends that users of the strips call Abbott for replacements and seek advice from a pharmacist while waiting for the new tests to arrive. The FDA and the company are reviewing the cause of the defect to avoid the problem in the future, according the agency.