FDA regulators placed their highest-risk label on Abbott Diabetes Care’s (NYSE:ABT) recall of certain blood glucose testing strips, warning that falsely low readings could prevent patients from properly responding to high blood sugar levels.
Abbot last month issued a recall of certain FreeStyle and FreeStyle Lite test strips after receiving reports of the devices providing erroneously low readings. The strips in question are used with the company’s own FreeStyle and FreeStyle Flash glucose meters, as well as FreeStyle systems that are built into Insulet‘s (NSDQ:PODD) OmniPod glucose management system.
"Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death," according to the FDA notice. "An erroneously low blood glucose result may lead to failure to diagnose and appropriately treat high blood sugar (hyperglycemia) or inappropriate treatment. Treatment of an erroneously low glucose result may lead to too much carbohydrate intake or insulin under dose, and could result in hyperglycemia and other serious adverse health consequences, including death."
Abbott’s diabetes division has issued a handful of recalls in recent years, including another recall over falsely low results. The company in 2010 pulled some 360 million blood glucose tests strips spanning 6 different product lines.
Abbott last April recalled its FreeStyle Insulinx blood glucose meter after discovering a software glitch that could deliver incorrect results