Abbott Recalls Older Freestyle Glucose Monitoring Systems

Miriam E. Tucker

Disclosures

February 25, 2014

(Corrected) Abbott Diabetes Care has issued a recall of its FreeStyle Flash Blood Glucose Monitoring System  and FreeStyle Blood Glucose Monitoring System.

In addition, users of the Omnipod Insulin Management System are being asked to stop using the monitor built into the Personal Diabetes Manager until Abbott can replace the Freestyle glucose test strips with new ones that will work with that meter.

This recall does not apply to the newer Abbott glucose meters: Freestyle Freedom, Freestyle Lite, and Freestyle Freedom Lite. Testing has shown that results are accurate with these newer meters when used with their approved Freestyle glucose test strips, according to a statement provided to Medscape Medical News by Abbott Diabetes Care.

Abbott says it has recently determined that, when used with the older meters, Freestyle strips can issue erroneously low blood glucose results. The Freestyle and FreeStyle Flash meters have not been produced since 2010. The recall affects approximately 1% of the consumer base that uses Abbott's Freestyle meters, the statement notes.

In November 2013, Abbott issued a voluntary recall of 20 specific lots of FreeStyle and FreeStyle Lite blood glucose test strips in the United States. The current monitoring system recall expands that.

The root problem appears to be a strip manufacturing process error that expresses only when a strip is used with a non–applied voltage meter, as are included in the 3 affected devices, leading to a decreased response in the system glucose readings. Newer meters with applied voltage are not affected and do not express a reduced response in the system glucose readings, according to the Abbott statement.

Users of the FreeStyle Flash Blood Glucose Monitoring System and the FreeStyle Blood Glucose Monitoring System are instructed to call Abbott Diabetes Care Customer service at 1-888-345-5364 to receive a free Freestyle-branded replacement meter.

OmniPod users can receive replacement strips at no cost by contacting Abbott Diabetes Care Customer Service at 1-877-584-5159.

Editor's note: An earlier version of this story stated that the glucose strips were being recalled; it is instead the older meters.

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