The FDA appears to be issuing another Class I designation involving Abbott Laboratories' voluntary recall of diabetes products.
Back in January, the FDA said FreeStyle and FreeStyle Lite test strips could cause serious injury or death 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.)
Late last week, an additional Class I designation was announced involving the actual FreeStyle and FreeStyle Flash Blood Glucose Meters, including the FreeStyle Blood Glucose Meter built into the OmniPod Personal Diabetes Manager.
The FDA says: "Abbott Diabetes Care has identified that certain meters have the potential to produce erroneously low blood glucose results when used in conjunction with certain Free Style test strips."
Abbott has asked users of the FreeStyle and FreeStyle Flash Blood Glucose Meters to discontinue, and to call Abbott for a new unaffected meter. Those using a built-in FreeStyle meter in the OmniPod Personal Diabetes Manager should discontinue use of affected test strips and call Abbott for replacement unaffected test strips.
Refresh your medical device industry knowledge at MD&M East, June 9-12, 2014 in New York City.
When Abbott announced its 2013 results on January 22 the company came in a little shy of growth expectations for the second straight quarter. The company's latest quarterly results are due out before the market opens on Wednesday.
