Updated March 17, 2014, at 4:30 pm. with comments from Abbott.
Abbott (NYSE:ABT) issued a recall of its FreeStyle and FreeStyle Flash blood glucose meters, warning that the devices may produce falsely low readings when paired with the FreeStyle test strips.
The recall extended further to users of Insulet’s (NSDQ:PODD) OmniPod systems with built-in FreeStyle blood glucose meters, Abbott reported in a letter to patients last month. Abbott advised OmniPod patients to use alternate test strips and to watch for symptoms of high blood sugar.
The recalled devices haven’t been in production since 2010, according to an FDA memo. Abbott determined that the root cause was a manufacturing defect in certain lots of the test strips themselves, company spokeswoman Jessica Sachariason told MassDevice.com. When used with non-applied voltage meters like the older FreeStyle systems, the test strips produced inaccurate readings.
"Newer technology based meters with applied voltage – such as the FreeStyle Freedom Lite – are not impacted and do not express a decreased response in the system glucose readings," Sachariason said. "The strip manufacturing error was recent, so as a precaution, we are replacing all of the older meters with newer meters."
Abbott began reaching out to users of older FreeStyle systems about a month ago, "immediately after the issue was discovered," the FDA agency said. The affected users comprise about 1% of total FreeStyle patients, Sachariason told us.
The recall doesn’t apply to newer FreeStyle systems. Freestyle Lite, Freestyle Freedom Lite and Freestyle InsuLinx devices may continue to be used with the FreeStyle test strips without issue, according to another FDA notice.
Abbott’s FreeStyle test strips had previously been recalled over over "the manufacturing process error" that resulted in falsely low readings. In November 2013 Abbott recalled the strips after discovering errors when paired with the FreeStyle and FreeStyle Flash glucose meters. The FDA gave that recall it’s highest-risk Class I rating after deeming the issue a risk of potential injury or death.
Abbott last April recalled its FreeStyle InsuLinx blood glucose meters after discovering a software glitch that could deliver incorrect results. The company in December 2010 recalled nearly 360 million Precision Xtra, Precision Xceed Pro, MediSense Optium, Optium, OptiumEZ and ReliOn Ultima test over more falsely low readings.
ABT shares were up 1.4% to $39.53 as of about 12:25 p.m. today. The stock has gained 2.7% since the start of the year.
