FDA has recently given Class I status to a recall of Abbott Laboratories' FreeStyle and FreeStyle Lite test strips, which indicates that the products could cause serious injury or death. Abbott voluntarily recalled the strips because they were found to provide inaccurate readings of blood glucose when used with the FreeStyle and FreeStyle Flash meters and the Insulet OmniPod. The FreeStyle and FreeStyle Flash devices have not been produced since 2010.
In a press release, Abbot explained that the problem in question did not occur with its newer FreeStyle Freedom, Lite and Freedom Lite meters. However, by possibly producing inaccurately low test results for blood glucose levels, the FreeStyle and FreeStyle Lite test strips could raise a diabetics' risk of hypoglycemia, which can lead to unconsciousness, seizures, or death in severe cases.
Abbott announced the recall of 20 lots of the two FreeStyle-branded test strip lines on 27 November 2013.
The company also had an earlier Class I recall of its FreeStyle InsuLinx meters in the spring, which were found to work incorrectly with abnormally high blood glucose levels.
