Events

Retiro De Equipo (Recall) de VITROS Chemistry Products PHYT 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 Australia Pty Ltd.

¿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-2018-RN-00604-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2018-05-23
  • 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-2018-RN-00604-1
  • 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
    Ortho has confirmed customer complaints regarding the potential for imprecise results when using impacted vitros phyt slides. the results obtained were either positively or negatively biased across the vitros phyt slides measuring range of 3.00–40.00 ug/ml (11.88–158.40 umol/l).To date, no adverse events have been reported as a result of this issue.
  • Acción
    Ortho is requesting customers to immediately discontinue using and discard all remaining inventory of VITROS PHYT Slides for the affected lots. Ortho will replace remaining inventory of the affected lots or credit accounts.

Device

VITROS Chemistry Products PHYT Slides. An in vitro diagnostic medical device (IVD).
  • Modelo / Serial
    VITROS Chemistry Products PHYT Slides. An in vitro diagnostic medical device (IVD).Unique Identifier Number:10758750004690Product Code: 8298671Generation: GEN 16Coating ID: Coating 0165Multiple Lot NumbersExpiry date:15 March 2018 through to 15 June 2018ARTG Number: 245278
  • Manufacturer
    Ortho-Clinical Diagnostics Australia Pty Ltd

Manufacturer

Ortho-Clinical Diagnostics Australia Pty Ltd