Events

Retiro De Equipo (Recall) de VITROS Chemistry Products Na+ 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-2017-RN-00004-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2017-01-04
  • 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-2017-RN-00004-1
  • 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
    An issue has been identified where there is a potential for biased results to be generated over the 10 day on-analyzer limit when using vitros na+ slide cartridges warmed between 1½ to 8 hours prior to being placed on the analyser. it has been determined that cartridges require a minimum of 8 hours of warm up at room temperature to help ensure the slides have acceptable performance throughout the 10 day on-analyser storage limit. this issue affects all expired, in-date gens, and future product until further notice.
  • Acción
    Ortho Clinical Diagnostics is advising customers to store cartridges at room temperature for a minimum of eight (8) hours prior to calibration. Customers who have discarded cartridges will have their account credited or be sent a replacement.

Device

VITROS Chemistry Products Na+ Slides. An in vitro diagnostic medical device (IVD)

Manufacturer

Ortho-Clinical Diagnostics Australia Pty Ltd