ADVOCATE Redi-Code+ BMB-BA006A Blood Glucose test strips Product Usage: The ADVOCATE Redi-Code+ BMB-BA006A Blood Glucose

FDA device recall Z-2021-2014 · posted 2014-07-22 · Terminated

Recall details

Recalling firm

DIABETIC SUPPLY OF SUNCOAST, INC.

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".

Action taken

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.

Root cause

Labeling False and Misleading

Status

Terminated

Product code

CGA

Quantity affected

1,852,800 cases (50 strips ea)

Distribution

Worldwide Distribution - USA (nationwide) and Internationally to Venezuela, Ecuador, Canada & Vietnam

Date initiated

2014-05-05

Date posted

2014-07-22

Date terminated

2017-06-13

Location

Dorado, PR

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