The maker of multiple brands of glucose test strips -- Abbott Diabetes Care -- issued a voluntary recall of several hundred product lots of the test strips, due to falsely low readouts of blood glucose which could result in over- or under-treatment of diabetic patients.
The FDA warned that false results from glucose test strips may lead diabetic patients to try to raise their blood glucose unnecessarily, or they may fail to treat elevated blood glucose because of a false, low reading -- both scenarios posing a health threat.
The reason for the inaccurate results is that the recalled test strips may fail to absorb sufficient blood to give true glucose readouts -- particularly if the products are stored in a warm environment or for a long period of time, the agency explained.
Abbott Diabetes Care pulled strips from shelves marketed under several brand names, including:
* Precision Xceed Pro
* Precision Xtra
* Medisense Optium
* Optium
* OptiumEZ
* RellOn Ultima
The recall affects 359 product lots and up to 359 million test strips that were manufactured from January to May 2010, the statement said. The strips were marketed to both consumers and to healthcare professionals.
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