FDA Medical Device Recalls (openFDA)
DIABETIC SUPPLY OF SUNCOAST, INC.: 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.
- Recall number
- Z-2021-2014
- Recalling firm
- DIABETIC SUPPLY OF SUNCOAST, INC.
- 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.
- Status
- Terminated
- Initiated
- 2014-05-05
- Posted
- 2014-07-22
- Terminated
- 2017-06-13
- Reason
- "Advocate Redi-Code + BMB-BA006A Blood Glucose test strips" are inappropriately labeled and marketed as "Advocate Redi-Code + Blood Glucose test strips".
- Root cause
- 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
- 1,852,800 cases (50 strips ea)
- Distribution
- Worldwide Distribution - USA (nationwide) and Internationally to Venezuela, Ecuador, Canada & Vietnam
- Lot, serial or model codes
- All test strips lots manufactured from June 01, 2012 to January 01, 2014.. No specific lot numbers provided.
- 510(k) numbers
- ["K120183"]
- PMA numbers
- not on file
- Product code
- CGA
- Firm FEI
- 3005861699
- Firm city
- Dorado
- Firm state
- not on file
- Firm country
- PR
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28