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Labeling Error on Blood Glucose Test Strips; Nationwide Recall


Diabetic Supply of Suncoast, Inc., initiated a nationwide voluntary recall of all BMB-BA006A Advocate Redi-Code+ blood glucose test strip lots manufactured by BroadMaster Bio-Tech Corp. The Advocate Redi-Code+ BMB-BA006A blood glucose test strips were recalled due to a labeling error which could result in confusion about which meter models the Redi-Code+ BMB-BA006A blood glucose test strips are designed to be used with. In the incorrect labeling, the test strips’ model (BMB-BA006A) was omitted.

 

This error may lead users to believe they can use the Advocate Redi-Code+ BMB-BA006A blood glucose test strips with the Advocate Redi-Code blood glucose meters, model numbers TD-3223E, TD-4223E, TD-4223F, TD-4276 manufactured by Taidoc Technology Corp. The Advocate Redi-Code+ BMB-BA006A blood glucose test strips should only be used with the Advocate Redi-Code+ BMB-EA001S and EA001A blood glucose meters manufactured by BroadMaster Bio-Tech Corp.

 

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 above, 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.

 

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See also Medical Law Perspectives, May 2014 Report: Diabetes and Its Complications: Malpractice and Other Liability Issues 

 

 

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