June 12, 2014

Advocate Redi-Code+ Blood Glucose Test Strips by Diabetic Supply of Suncoast: Recall- Labeling Error

The Missouri Department of Health and Senior Services received information regarding a recall of all BMB-BA006A Advocate Redi-Code+ blood glucose test strip lots manufactured by BroadMaster Bio-Tech Corp. The recall is due to a labeling error that could result in confusion about which meter models are to be used with the Redi-Code+ BMB-BA006A blood glucose test strips.

In the incorrect labeling, the test strips model (BMB-BA006A) was omitted. Suncoast is recalling the test strips in an effort to avoid confusion and the possible misuse of the Advocate Redi-Code+blood glucose test strips with the Taidoc meters listed in the Firm Press Release, which could result in incorrect glucose results.

Falsely high or falsely low glucose results could potentially cause missed or delayed hyperglycemia or hypoglycemia detection and lead to no treatment or inappropriate treatment. Delayed or inappropriate treatment of hyperglycemic or hypoglycemic states could lead to serious health consequences, including death.

The full recall can be found at www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm400668.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery.