Events

Retiro De Equipo (Recall) de Device Recall Benchmark & Discovery

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 Ventana Medical Systems 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
    49516
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2118-2013
  • Fecha de inicio del evento
    2008-06-12
  • Fecha de publicación del evento
    2013-08-28
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-08-29
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=73710
  • 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
    Slide stainer, automated - Product Code KPA
  • Causa
    Ventana medical system is initiating the recall of the benchmark and discovery series instruments because there is a possibility that the heating element could separate from the underside of the heater cap and cause a non-staining or inconsistent staining event. additionally, the system may not detect this anomaly and therefore it may not generate an error message for the slide position.
  • Acción
    Ventana sent an Urgent Medical Device Correction Notification letter dated June 16, 2008 to all affected customers. The letter identifed the affected product, problem and actions to be taken. The letter instructed customers to carefully read and perform all of the actions outlined in the notification letter concerning potential safety issue. Customers with concerns regarding the staining results on any patient specimen are instructed to follow their internal Quality Procedures regarding the review of patient reports. For question contact your local Customer Service Center.

Device

Device Recall Benchmark & Discovery
  • Modelo / Serial
    BenchMark XT Instruments-S/N: 711869-712465; BenchMark LT instruments-S/N: 610321-610345. Discovery XT Instruments-S/N: 610321-610345.
  • Clasificación del producto
    Hematology and Pathology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA Nationwide and the countries of Canada, Europe, Asia, Japan.
  • Descripción del producto
    Benchmark XT/LT and Discovery XT || Model Numbers: N750-BMK-FS, N750-BMKXT-FS, N750-BMKLT-FS, N750-DIS-FS, N750-DISXT-FS. || Product Usage: Usage: || The Benchmark product lines are intended to automatically stain histological or cytological specimens on microscope slides with specific immunohistochemistry or in situ hybridization reagents for in vitro diagnostic use. The Discovery Systems are research use only instruments with similar functionality.
  • Manufacturer
    Ventana Medical Systems Inc

Manufacturer

Ventana Medical Systems Inc
  • Dirección del fabricante
    Ventana Medical Systems Inc, 1910 E Innovation Park Dr, Tucson AZ 85755
  • Empresa matriz del fabricante (2017)
    Roche Holding Ag
  • Source
    USFDA