Events

Retiro De Equipo (Recall) de Rotor Yokes (used in Allegra X-5 Centrifuge). 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 Beckman Coulter 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-2016-RN-00174-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-02-11
  • 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-00174-1
  • 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
    A defective rotor yoke allows improper rotor seating on the hub resulting in possible rotor failure if the buckets are loaded in an imbalanced configuration.If the rotor becomes unbalanced it may vibrate excessively and/or exhibit smoke if the rotor is rubbing inside the centrifuge.There is a chance of physical injury to users as a result of the vibration if the issue occurs. there is also a remote risk of a delay in results if the failure occurs.
  • Acción
    Beckman Coulter is replacing the affected rotor yokes. The centrifuge can continue to be used, as long as all runs are balanced appropriately.

Device

Rotor Yokes (used in Allegra X-5 Centrifuge). An in vitro diagnostic medical device (IVD)
  • Modelo / Serial
    Rotor Yokes (used in Allegra X-5 Centrifuge). An in vitro diagnostic medical device (IVD)Rotor Yokes Part Number: B30593Lot Numbers: 322/13 and 355/13ARTG Number: 177999
  • Manufacturer
    Beckman Coulter Australia Pty Ltd

Manufacturer

Beckman Coulter Australia Pty Ltd