Events

Retiro De Equipo (Recall) de VITROS 3600, 4600, 5600, 5,1 FS Chemistry Systems. An in vitro diagnostic medical device (IVD)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Ortho-Clinical Diagnostics.

¿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
    RC-2013-RN-01219-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2013-11-21
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01219-1
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Notas adicionales en la data
  • Causa
    The manufacturer has received reports regarding a potential malfunction in a wire connector used in the vitros systems. there have been reports of the smell of melting plastic or smoke originating from the affected systems.
  • Acción
    Ortho Clinical Diagnostics is correcting the wire connector to prevent the occurance of over heating.

Device

VITROS 3600, 4600, 5600, 5,1 FS Chemistry Systems. An in vitro diagnostic medical device (IVD)
  • Modelo / Serial
    VITROS 3600, 4600, 5600, 5,1 FS Chemistry Systems. An in vitro diagnostic medical device (IVD)VITROS 3600 Immunodiagnostic Systems (Product Code 6802783)VITROS 4600 Chemistry Systems (Product Code 6802445)VITROS 5600 Integrated Systems (Product Code 6802413)VITROS 5,1 FS Chemistry Systems (Product Code 6801375, 6801890)
  • Manufacturer
    Ortho-Clinical Diagnostics

Manufacturer

Ortho-Clinical Diagnostics