June 11, 2014 — The U.S. Food and Drug Administration (FDA) has issued a Safety Alert for blood-sugar test strips that were sold with a labeling error in which the model-number was omitted.
The agency is concerned that users could get confused about which meters the test strips work with, which could lead to incorrect blood-sugar readings.
The recall affects all BMB-BA006A Advocate Redi-Code+ test strips sold nationwide. They are only supposed to be used with the Advocate Redi-Code+ BMB-EA001S and EA001A blood glucose meters manufactured by BroadMaster Bio-Tech Corp.
The distributor, Diabetic Supply of Suncoast, Inc., warns that the recalled test strips should not be used with th Advocate Redi-Code blood glucose meters, model numbers TD-3223E, TD-4223E, TD-4223F, TD-4276 manufactured by Taidoc Technology Corp.
According to the FDA, incorrect blood-sugar readings could lead to life-threatening health consequences:
“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.”
If you own the recalled test strips, contact Diabetic Supply of Suncoast, Inc. for more information. They will help you determine if you are using the recalled test strips properly. The company is offering to replace the test strips with relabeled boxes that will help avoid confusion.
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