June 11, 2014 — Diabetic Supply of Suncoast, Inc., is recalling all BMB-BA006A Advocate Redi-Code+ blood-sugar test strips that were manufactured by BroadMater Bio-Tech Corp due to a labeling error that could be confusing about which meter models the test strips are designed to be used with.
According to the FDA Safety Alert, the recalled test strip model (BMB-BA006A) was omitted. This model should only be used with the Advocate Redi-Code+ BMB-EA001S and EA001A blood glucose meters manufactured by BroadMaster Bio-Tech Corp.
Without the model number on the label, users may falsely 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.
This error could result in incorrect blood-sugar readings. The FDA warns:
“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.”
Customers who own the recalled test strips should contact Diabetic Supply of Suncoast, Inc., for information on how to determine if the test strips are being used properly or if they need to be returned to Suncoast. The company will replace recalled test strips with relabeled boxes to avoid confusion.
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