Medical Device Safety and Recalls: Abbott Diabetes Care, Inc. FreeStyle and FreeStyle Flash Blood Glucose Meters including the FreeStyle Blood Glucose Meter built into the OmniPod Personal Diabetes Manager (PDM)

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. This issue occurs with FreeStyle, FreeStyle Flash Blood Glucose meters and the FreeStyle blood glucose meter built into the OmniPod Insulin Management System. Affected meters and test strips have been identified by Abbott and customer notification letters with specific instructions for each product have been issued.  For more information, please see

This email was sent to using GovDelivery, on behalf of: U.S. Food & Drug Administration (FDA) · 10903 New Hampshire Ave · Silver Spring, MD 20993 · 800-439-1420 Powered by GovDelivery