Events

Retiro De Equipo (Recall) de TCAutomation System with Thermo Scientific Recapper (used with VITROS Automation Solutions). 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-2016-RN-00352-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-03-24
  • 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-2016-RN-00352-1
  • 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 electrical cable that supplies power to the cap vibratory feeder of the recapper module may loosen from its correct position above the vibration feeder support plate and migrate to under the support plate. if this occurs, the uncapped sample tubes may hit the cable, and sample fluid (e.G., serum) may splash from the tube and into another tube or onto the under carriage of the support plate. this may result in contamination of patient samples and affect patient diagnosis or treatment.
  • Acción
    Ortho Clinical is advising users to check the affected systems to identify if the electrical cable has migrated out of position. A Service Representative will secure the cable in place above the support vibration feeder plate. This action has been closed-out on 09/05/2017.

Device

TCAutomation System with Thermo Scientific Recapper (used with VITROS Automation Solutions). An i...
  • Modelo / Serial
    TCAutomation System with Thermo Scientific Recapper (used with VITROS Automation Solutions). An in vitro diagnostic medical device (IVD)TCAutomation SystemProduct Code: 6844300Thermo Scientific Recapper Module (230V)Product Code: 952036
  • Manufacturer
    Ortho-Clinical Diagnostics

Manufacturer

Ortho-Clinical Diagnostics