Events

Recall of Device Recall Advocate RediCode BMBBA006A Blood Glucose Test Strips

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by DIABETIC SUPPLY OF SUNCOAST, INC..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    68196
  • Event Risk Class
    Class 1
  • Event Number
    Z-2021-2014
  • Event Initiated Date
    2014-05-05
  • Event Date Posted
    2014-07-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-06-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=127125
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Glucose oxidase, glucose - Product Code CGA
  • Reason
    "advocate redi-code + bmb-ba006a blood glucose test strips" are inappropriately labeled and marketed as "advocate redi-code + blood glucose test strips".
  • 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.

Device

Device Recall Advocate RediCode BMBBA006A Blood Glucose Test Strips
  • Model / Serial
    All test strips lots manufactured from June 01, 2012 to January 01, 2014.. No specific lot numbers provided.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and Internationally to Venezuela, Ecuador, Canada & Vietnam
  • Product Description
    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.
  • Manufacturer
    DIABETIC SUPPLY OF SUNCOAST, INC.

Manufacturer

DIABETIC SUPPLY OF SUNCOAST, INC.
  • Manufacturer Address
    DIABETIC SUPPLY OF SUNCOAST, INC., Barrio Espinosa Road #2 Km 26.2, Dorado PR 00646
  • Source
    USFDA