Events

Rappel de BD Biosciences FACSDiva Software Versions 4.0.1 to 5.0.2

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 BD Biosciences.

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
    38337
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1525-2008
  • Date de mise en oeuvre de l'événement
    2007-04-05
  • Date de publication de l'événement
    2008-08-16
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2009-09-30
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=53455
  • 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
    Differential Cell Counter - Product Code GKZ
  • Cause
    When data file containing one or no fluoresence parameters is exported, the software will automatically apply compensation to this file and all subsequently exported files.
  • Action
    The firm has issued a customer Important Product Information letter via mail on 04/20/2007 to inform them of the software issues. The letter states that to avoid this problem, make sure each tube or well has at least two fluorescence parameters before exporting FCS 3.0 data files. Manually exporting tubes or wells one at a time or restarting the software after the export of an FCS data file containing one or no fluorescence parameters will prevent the problem from occurring. Customers are requested to fill out and return the response form and to contact BD Customer Support Center if there are any additional questions. A software fix is being developed in version 6.0 and a free maintenance release with no product enhancments (version 5.0.3).

Device

BD Biosciences FACSDiva Software Versions 4.0.1 to 5.0.2
  • Modèle / numéro de série
    Software versions 4.0.1 to 5.0.2.
  • Classification du dispositif
    Hematology and Pathology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution --- USA including states of NY, NM, MI, GA, MD, MA, AL, CA, VA, NC, OH, TX, CO, NJ, PA, MI, CT, IA, MO, NV, KY, IL, TN, FL, MN, FL, UT, WA, OK, CT, WI, SD, AZ, and IN, and countries of Buenos Aires, BE, Brazil, Canada, Chile, China, Hong Kong, Japan, Singapore, Taiwan, Venezuela, Mexico, Trinidad and Tobago, and Columbia.
  • Description du dispositif
    FACSDiva Software Versions 4.0.1 to 5.0.2, Flow Cytometry Acquisition & Analysis software. Catalog number 641609 || Flexible data acquistion and analysis package specifically designed for digital-based flow cytometers.
  • Manufacturer
    BD Biosciences

Manufacturer

BD Biosciences