Abbott has issued another FreeStyle blood glucose meter recall; this time for units that come with the Omnipod Personal Diabetes Manager (PDM), because they could provide users with erroneously low results, posing serious and potentially fatal consequences if the user takes the wrong course of medical action.
The FDA determined last week that an Abbott blood glucose meter recall announced last month should be classified as a class I medical device recall, meaning the agency believes the devices could cause serious injury or death.
The action came after Abbott identified that certain meters which were have the potential to produce significantly low glucose levels when used with certain Freestyle test strips, posing serious and sometime fatal health consequences to users.
The affected Freestyle and Freestyle Flash blood glucose meters are devices used by healthcare professionals and those with diabetes mellitus for home-use. The devices allow for individuals to monitor their blood glucose levels on a daily basis and receiving an inaccurate reading may cause the patient to pursue the wrong course of treatment putting them at an even higher risk of injury.
The recall includes Freestyle and Freestyle Flash blood glucose meter as well as the Freestyle blood glucose meters built into the OmniPod PDM. Abbott announced these are the only products affected that may produce inaccurately low result when used with the Freestyle test strips.
The glucose meters were manufactured by Abbott Diabetes Care Inc. of Alameda, California where they were sold nationwide.
On March 14, Abbott sent an Important: Urgent Product RECALL notice to all known customers using the affected Freestyle blood glucose meters built into the OmniPod Insulin Management System with instructions to discontinue the use of the Freestyle strips and to contact Abbott Diabetes Care Customer Service at 1-877-584-5159 for replacement test strips. Additionally, the firm sent another Urgent Recall Notice on February 19, informing all users of the Freestyle and Freestyle Flash blood glucose meters to discontinue use and to contact Abbott’s Diabetes Customer Care Service at 1-888-345-5364 to receive replacement meters at no charge.
This is Abbott’s second recall of glucose meters in the last few months, with the last recall occurring on November 18, 2013, due to the Freestyle and Freestyle Lite blood glucose meters producing significantly low glucose readings. The FreeStyle recall was later recategorized as a Class I recall after the FDA recognized it is one of the most serious forms of medical device recalls.
Class I recalls are considered the most serious because there is a reasonable probability that the use of the product may cause serious and adverse health consequences, including death.