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U.S. Department of Health and Human Services

Class 1 Device Recall Advocate RediCode BMBBA006A Blood Glucose Test Strips

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  Class 1 Device Recall Advocate RediCode BMBBA006A Blood Glucose Test Strips see related information
Date Initiated by Firm May 05, 2014
Date Posted July 22, 2014
Recall Status1 Terminated 3 on June 13, 2017
Recall Number Z-2021-2014
Recall Event ID 68196
510(K)Number K120183  
Product Classification Glucose oxidase, glucose - Product Code CGA
Product ADVOCATE Redi-Code+ BMB-BA006A Blood Glucose test strips

Product Usage: The ADVOCATE¿ Redi-Code+ BMB-BA006A Blood Glucose test strips are used only with the ADVOCATE¿ Redi-Code+ BMB-EA004S meter to quantitatively measure glucose in fresh capillary whole blood samples drawn from finger tips, the palm, the forearm, the upper arm, the calf, and the thigh.
Code Information All test strips lots manufactured from June 01, 2012 to January 01, 2014.. No specific lot numbers provided.
Recalling Firm/
Manufacturer		 DIABETIC SUPPLY OF SUNCOAST, INC.
Barrio Espinosa Road #2 Km 26.2
Dorado PR 00646
For Additional Information Contact Steven Thuss
787-270-6300
Manufacturer Reason
for Recall		 "Advocate Redi-Code + BMB-BA006A Blood Glucose test strips" are inappropriately labeled and marketed as "Advocate Redi-Code + Blood Glucose test strips".
FDA Determined
Cause 2		 Labeling False and Misleading
Action Diabetic Supply of Suncoast, Inc. sent an Urgent Voluntary Medical Device Recall letter dated June 6, 2014, to all affected consignees. The firm is asking the distributors to examine their inventory immediately and quarantine any product subject to recall. In addition, if they may have further distributed this product, to please identify their customers and notify them at once of this product recall. Customers who have the BMB-BA006A Advocate Redi-Code+ test strips can contact Diabetic Supply of Suncoast, Inc. directly for further information to determine if the products are being used in the proper manner or if they need to be returned to Suncoast for replacement. Test strips will be replaced with relabeled (with new labels) boxes of test strips to avoid any chance of confusion. Consumers should stop using the above mentioned product and contact Suncoast to find out if this recall pertains to the products they have in their possession and if so how to have them replaced for the relabeled product manufactured by BroadMaster Bio-Tech. Customers with questions should call Diabetic Supply of Suncoast, Inc. at 561-296-0488. For questions regarding this recall call 561-254-1007.
Quantity in Commerce 1,852,800 cases (50 strips ea)
Distribution Worldwide Distribution - USA (nationwide) and Internationally to Venezuela, Ecuador, Canada & Vietnam
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = CGA and Original Applicant = BROADMASTER BIOTECH CORPERATION
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