Events

Retiro De Equipo (Recall) de Device Recall Advocate RediCode BMBBA006A Blood Glucose Test Strips

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por DIABETIC SUPPLY OF SUNCOAST, INC..

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    68196
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-2021-2014
  • Fecha de inicio del evento
    2014-05-05
  • Fecha de publicación del evento
    2014-07-22
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-06-13
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=127125
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Glucose oxidase, glucose - Product Code CGA
  • Causa
    "advocate redi-code + bmb-ba006a blood glucose test strips" are inappropriately labeled and marketed as "advocate redi-code + blood glucose test strips".
  • Acción
    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
  • Modelo / Serial
    All test strips lots manufactured from June 01, 2012 to January 01, 2014.. No specific lot numbers provided.
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA (nationwide) and Internationally to Venezuela, Ecuador, Canada & Vietnam
  • Descripción del producto
    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.
  • Dirección del fabricante
    DIABETIC SUPPLY OF SUNCOAST, INC., Barrio Espinosa Road #2 Km 26.2, Dorado PR 00646
  • Source
    USFDA