Events

Retiro De Equipo (Recall) de VITROS Mixing Cup Arrays on VITROS 250 Chemistry Systems & VITROS 350 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-01270-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2013-12-02
  • 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-2013-RN-01270-1
  • 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
    While performing an on-analyser dilution, some customers have reported an increase in eae condition codes (sample metering dilution error). the data indicates that the rate of occurrence for eae codes can vary between 2 and 25% for cups within the affected arrays. when an eae condition code occurs, the processing for that sample is automatically cancelled by the system.Ortho-clinical diagnostic's investigation into the increased rate of eae condition codes determined that some of vitros mixing cup arrays may be out of specification.
  • Acción
    Ortho-Clinical Diagnostics is advising their customers to continue using the Mixing Cup arrays as there is currently no alternative available. It is recommended that laboratories perform manual dilutions for samples with low volume rather than using an onboard dilution. This action has been closed-out on 10/02/2016.

Device

VITROS Mixing Cup Arrays on VITROS 250 Chemistry Systems & VITROS 350 Chemistry Systems. An in vi...
  • Modelo / Serial
    VITROS Mixing Cup Arrays on VITROS 250 Chemistry Systems & VITROS 350 Chemistry Systems. An in vitro diagnostic medical device (IVD).Product Code: 1631779ARTG Number for VITROS Chemistry Systems:180199
  • Manufacturer
    Ortho-Clinical Diagnostics

Manufacturer

Ortho-Clinical Diagnostics