Z-2021-2014Class I

ADVOCATE Redi-Code+ BMB-BA006A Blood Glucose test strips

Name: Z-2021-2014 ADVOCATE Redi-Code+ BMB-BA006A Blood Glucose test strips
Creator: Diabetic Supply of Suncoast, Inc.
Published: 2014-05-05
License: https://open.fda.gov/license/

Diabetic Supply of Suncoast, Inc. / initiated 2014-05-05 / Terminated / root cause: labeling and UDI

FDA source

DIABETIC SUPPLY OF SUNCOAST, INC. began a recall of 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... on 2014-05-05. FDA classified it as Class I and gives the reason as ""Advocate Redi-Code + BMB-BA006A Blood Glucose test strips" are inappropriately labeled and marketed as "Advocate Redi-Code + Blood Glucose test strips"". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2021-2014
Classification: Class I
Status: Terminated
Initiated: 2014-05-05
Posted: 2014-07-22
Terminated: 2017-06-13
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.
Product code: CGA Glucose Oxidase, Glucose
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".
Root cause tag: labeling and UDI
FDA 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 in commerce: 1,852,800 cases (50 strips ea)
Distribution: Worldwide Distribution - USA (nationwide) and Internationally to Venezuela, Ecuador, Canada & Vietnam
Product codes and lots: All test strips lots manufactured from June 01, 2012 to January 01, 2014.. No specific lot numbers provided.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2021-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2021-2014	Class I	Terminated	Voluntary: Firm initiated	2014-07-30	2014-07-22

Product code CGA

K120183Class IIAdvocate Redi-Code+bmb-Ea001s Blood Glucose Monitoring SystemBroadmaster Biotech Corperation / cleared 2012-05-11

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)