A class I recall was issued for Abbott Diabetes Care glucose meters FreeStyle and FressStyle Flash Blood Glucose Meters, including the FreeStyle Blood Glucose Meter built into the OmniPod Personal Diabetes Manage (PDM). The recall, which was initiated on February 19th, was issued due to an error that can cause the meters to falsely give a low blood sugar reading. The Class I recall is the most dangerous recall status, and the FDA states that “Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.”
Healthcare professionals and patients who have diabetes use the meters to measure blood sugar levels (glucose). The meters help determine whether or not a diabetes control program is effective. In the Omnipod Personal Diabetes Manager, the FreeStyle meter is integrated.
The recalled was initiated because they can produce erroneously low glucose results when used in combination with certain FreeStyle test strips. The FreeStyle, FreeStyle Flash Blood Glucose Meters and the FreeStyle blood glucose meter built into the OmniPod Insulin Management System are can all have this error. Abbott said that anyone who uses the FreeStyle and FreeStyle Flash Blood Glucose Meters should stop using the devices. Customers who use the FreeStyle Blood Glucose Meter built into the OmniPod Personal Diabetes Manager should stop using the affected test strips. Replacement strips can be obtained by contacting Abbott Diabetes Care customer service.
The incorrect reading can be dangerous because they can fail to tell patients when their blood sugar levels are too high. Customers who use the recalled devices are told to be on the lookout for symptoms of high blood sugar, or hyperglycemia. This includes excessive thirst, excessive urination, blurred vision, weakness, nausea, vomiting and abdominal pain.
On February 14th, an “Important: Urgent Product RECALL” letter was sent to customers who use the FreeStyle Blood Glucose meter built into the OmniPod Insulin Management System. Another letter was sent on February 19th to customers who owned the FreeStyle Flash or FreeStyle Blood Glucose Meter.