Events

Rappel de Device Recall SensiDisc

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 Becton Dickinson & Co..

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
    37405
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0669-2007
  • Date de mise en oeuvre de l'événement
    2007-02-19
  • Date de publication de l'événement
    2007-03-29
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2007-07-09
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=50497
  • 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
    in vitro diagnostic - Product Code JTN
  • Cause
    Antibiotic susceptibility testing reagent was not manufactured according to specifications and may cause ineffective treatment regimen in patients with infections. the recalling firm received customer reports of false susceptibility results.
  • Action
    The recalling firm ceased distribution of the product on 01/15/07 and subsequently notified US distributors by faxed letter and international consignees by e-mail on 02/19/07. The notification advised distributors to discontinue and return remaining inventory for replacement. The consignees were instructed to return the accompanying response form indicating inventory counts for credit. The notice also requested distributors to provide within three days the end-user lists of those receiving the product for subsequent direct notification by the recalling firm. The notification to consignees was initiated on 02/22/07 by overnight courier. The consignee notification advised that the product will give false susceptible results when testing with the identified QC organism using the Kirby Bauer method. Consignees were instructed to immediately discontinue use and return prouct identified by lot 6167435, EXP 06/30/08 and reply by returning the enclosed response form. The firm recommended to end users, primarily laboratory and testing facilities, that patient isolates yielding susceptible results with the identified lot of Ticarcillin Sensi-disc which had not been tested with the QC organism, be retested and the physicians notified.

Device

Device Recall SensiDisc
  • Modèle / numéro de série
    Lot 6167435, exp 6/30/08
  • Classification du dispositif
    Immunology and Microbiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide, including USA, Australia, Canada, Hong Kong, Philippines, Belgium, Japan, Mexico, Singapore, Chile, India, and Venezuela.
  • Description du dispositif
    BD¿ Sensi-Disc¿ Ticarcillin TIC-75, in vitro diagnostic, catalog # 231619, package of 10 cartridges, labeled in part ***BD Diagnostic Systems, 7 Loveton Circle, Sparks, MD 21152***
  • Manufacturer
    Becton Dickinson & Co.

Manufacturer

Becton Dickinson & Co.
  • Adresse du fabricant
    Becton Dickinson & Co., 7 Loveton Cir, Sparks MD 21152-9212
  • Société-mère du fabricant (2017)
    Becton, Dickinson and Company
  • Source
    USFDA