Events

Rappel de BD FocalPoint"

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 Tripath Imaging, 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
    61444
  • Classe de risque de l'événement
    Class 3
  • Numéro de l'événement
    Z-1638-2012
  • Date de mise en oeuvre de l'événement
    2011-10-06
  • Date de publication de l'événement
    2012-05-21
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-12-03
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=108121
  • 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
    Processor, cervical cytology slide, automated - Product Code MKQ
  • Cause
    The cable tie mounts that adhere to the inside of the focalpoint do not adhere as intended and can therefore become detached.
  • Action
    BD Diagnostics first notified consignees by letter on October 6, 2011. BD Diagnostics also sent a letter dated February 2012, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the consignee. Field Representatives were advised to inspect all cables, adhesive cable ties and connections to ensure they are secure. Inspections and repairs, if necessary, would be carried out at the next service call for each instrument, or no later than the next regularly scheduled preventative maintenance visit. For questions consignees were instructed to contact BD Diagnostics Technical Support at 1-877-822-7771 option 2 in the US, their local distributor, or their local BD office for any questions. For questions regarding this recall call 918-563-1624.

Device

BD FocalPoint"
  • Modèle / numéro de série
    To be obtained
  • Classification du dispositif
    Hematology and Pathology Devices
  • Classe de dispositif
    3
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA including AZ, CT, IL, IN, FL, MN, NC, OK, OR, and TX and the countries of Australia, Belgium, Brazil, Canada, Japan and Thailand
  • Description du dispositif
    BD Focal Point"230V LC (Refurbished), Catalog number: 490681. || The BD Focal Point" Slide Profiler (formerly the AutoPap¿¿ System) is an automated cervical cytology screening device intended for use in initial screening of cervical cytology slide.
  • Manufacturer
    Tripath Imaging, Inc.

Manufacturer

Tripath Imaging, Inc.
  • Adresse du fabricant
    Tripath Imaging, Inc., 780 Plantation Dr, Burlington NC 27215-6723
  • Société-mère du fabricant (2017)
    Becton, Dickinson and Company
  • Source
    USFDA