Events

Retiro De Equipo (Recall) de Device Recall QCA and iQCA Software

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 Leica Microsystems, Inc..

¿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
    50163
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1040-2009
  • Fecha de inicio del evento
    2008-11-06
  • Fecha de publicación del evento
    2009-03-24
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-03-16
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=74885
  • 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
    Digital Analyzer - Product Code NQN
  • Causa
    A change in the software to open up the software architecture to include other analytes other than estrogen receptor was made without fda review and approval.
  • Acción
    Leica Microsystems sent Medical Device Correction letters dated 11/6/08 to the direct accounts, informing them that all versions 3.7 and above of QCA and iQCA software are not in compliance with the original 510(k) cleared software for scoring of immunohistochemical stains in clinical applications. The QCA/iQCA software is only cleared for Estrogen Receptor staining under clinical applications. The accounts were provided with red warning stickers that state: "WARNING The clinical application of QCA software has been cleared only for the measurement of images from microscopic slides of breast cancer specimens stained for the presence of estrogen (ER) nuclear receptor protein only. Performance characteristics of the product, when used outside of this intended use, have not been established." They were instructed to apply the stickers to any existing manuals and or at each point of use, and to instruct all users about the notification. The accounts were also requested to complete and return the enclosed reply form confirming that the changes have been made.

Device

Device Recall QCA and iQCA Software
  • Modelo / Serial
    all software versions 3.7 and above
  • Clasificación del producto
    Hematology and Pathology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution -- including states of CA, IL, KS, and NY.
  • Descripción del producto
    QCA and iQCA software, a video microscopy software system for quantitative estrogen receptor immunohistochemistry; Cell Analysis Inc., Evanston, IL 60201 or Highland Park, IL 60035. || Intended to measure and quantitate the percentage and intensity of positively stained nuclei in formalin-fixed, paraffin-embedded tissue specimens immunohistochemically stained for estrogen receptors. Indicated for use as an aid in the management, prognosis and prediction of therapy outcomes of breast cancer when used with reagents validated for those indications.
  • Manufacturer
    Leica Microsystems, Inc.

Manufacturer

Leica Microsystems, Inc.
  • Dirección del fabricante
    Leica Microsystems, Inc., 2345 Waukegan Rd, Bannockburn IL 60015-1515
  • Source
    USFDA