Events

Retiro De Equipo (Recall) de VITROS Chemistry Products DGXN Slides; 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-2012-RN-00658-3
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2012-07-02
  • 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-2012-RN-00658-3
  • 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
    Ortho-clinical diagnostics, inc. (ocd) recently received complaints of elevated results using heparin plasma samples for vitros chemistry products dgxn slides. as a result of their investigation into these complaints, heparin plasma is being removed as a recommended specimen type for vitros dgxn slides.
  • Acción
    Laboratories are being advised to immediately discontinue using heparin plasma for VITROS DGXN Slides and to discuss previously reported results with the Laboratory Medical Director to determine appropriate course of action. Update your laboratory's Instructions for Use (IFU) Manual with the revised instructions that are provided with the recall notice.

Device

VITROS Chemistry Products DGXN Slides; An in vitro diagnostic medical device (IVD)
  • Modelo / Serial
    VITROS Chemistry Products DGXN Slides; An in vitro diagnostic medical device (IVD)Product Code: 8343386
  • Manufacturer
    Ortho-Clinical Diagnostics

Manufacturer

Ortho-Clinical Diagnostics