Events

Rappel de Device Recall Advocate RediCode BMBBA006A Blood Glucose Test Strips

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par DIABETIC SUPPLY OF SUNCOAST, INC..

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    68196
  • Classe de risque de l'événement
    Class 1
  • Numéro de l'événement
    Z-2021-2014
  • Date de mise en oeuvre de l'événement
    2014-05-05
  • Date de publication de l'événement
    2014-07-22
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-06-13
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=127125
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Glucose oxidase, glucose - Product Code CGA
  • Cause
    "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
  • Modèle / numéro de série
    All test strips lots manufactured from June 01, 2012 to January 01, 2014.. No specific lot numbers provided.
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and Internationally to Venezuela, Ecuador, Canada & Vietnam
  • Description du dispositif
    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.
  • Adresse du fabricant
    DIABETIC SUPPLY OF SUNCOAST, INC., Barrio Espinosa Road #2 Km 26.2, Dorado PR 00646
  • Source
    USFDA