Events

Retiro De Equipo (Recall) de BD PrepStain System

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 Bd Diagnostic Systems Tripath.

¿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
    49548
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1090-2009
  • Fecha de publicación del evento
    2009-03-19
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-01-15
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=73784
  • 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
    Cervical Cytology Slide Processor - Product Code MKQ
  • Causa
    Software error in the non-gyn program of some devices may cause non-gyn samples to be incorrectly transferred from centrifuge tubes to slides potentially result in mismatched patient results.
  • Acción
    BD Diagnostics began contacting known non-gyn customers by phone on 09/26/2008. Customers were notified by Urgent - Important Product Information letter on 09/29/2008. They were advised to stop using the system until they complete a list of actions provided in the letter. A telephone contact number for Technical Support was provided in the letter. A permanent software based solution will be provided to customers when completed. They anticipate the software will be available in October 2008.

Device

BD PrepStain System
  • Modelo / Serial
    GYN software version 1.2, Non-GYN version 2.80; GYN software version 1.3.0.1, Non-GYN software version 2.80.
  • Clasificación del producto
    Hematology and Pathology Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution
  • Descripción del producto
    BD PrepStain System, Model Number: 799-14000-00; Catalog Number: 05CR000021, 05CR00021R, 799-13000-00, 799-13000-00R, 799-14000-00 and 799-14000-00R; Catalog Number: 05CR000021, 05CR000021R, 799-13000-00, 799-13000-00R, 799-14000-00 and 7914000-00R. || PrepStain is a liquid-based thin layer cell preparation device for preparation and staining of Prep smear slides from cervical specimens in a liquid based format (gyn use) and of cytology examination slides from non-cervical specimens such as urine and lung lavage.
  • Manufacturer
    Bd Diagnostic Systems Tripath

Manufacturer

Bd Diagnostic Systems Tripath
  • Dirección del fabricante
    Bd Diagnostic Systems Tripath, 4025 Stirrup Creek Dr, Durham NC 27703-9398
  • Empresa matriz del fabricante (2017)
    Becton, Dickinson and Company
  • Source
    USFDA