Our Blog / the diabetes online community on accuracy

From : http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm400668.htm


[Posted 06/11/2014]

AUDIENCE: Consumer, Family Physician, Pharmacy

ISSUE: 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 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. 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.

BACKGROUND: Diabetic Supply of Suncoast, Inc. is notifying its wholesale Distributors, Pharmacies, Medical Supply stores, Health Care Providers and direct customers throughout the entire US and Virgin Islands by letter and Press Release about the specifics of the recall.

RECOMMENDATION: Customers who have the affected test strips can contact Diabetic Supply of Suncoast, Inc. directly for further information. Test strips will be replaced with relabeled boxes of test strips to avoid any chance of confusion. Consumers should stop using the above mentioned test strips and contact Suncoast to find out if this recall pertains to the test strips they have in their possession and if so how to have them replaced for the relabeled products manufactured by BroadMaster Bio-Tech.

Customers with questions may contact Diabetic Supply of Suncoast at (561) 296-0488 between the hours of 9:00AM and 5:00PM Monday through Friday Eastern standard time or view the information at www.dsosi.com.

Customers who have the Advocate Redi-Code blood glucose meters manufactured by Taidoc Technology Corp should follow the product User Manual for information about the appropriate test strips to be used with the Taidoc meters.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:
Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Bennet Dunlap

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