Events

Retiro De Equipo (Recall) de Recapper for the AutoMate 2500 Family. 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-2017-RN-00748-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-06-27
  • 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-00748-1
  • 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
    Beckman coulter has identified there is a potential that a component on the recapper module did not have the required coating specified for that part.The coating on the recapper component helps to ensure both the longevity of the part, and help the gripper to release the parafilm so it properly seals to the tube. if there is an uncoated component on your recapper, this could lead to the tubes not being properly sealed. in the worst case scenario, this could cause sample cross contamination and subsequent misdiagnosis.
  • Acción
    Beckman Coulter will schedule a time to visit affected users to confirm whether the proper coating on the recapper component is present, and replace the component. In the interim, users are advised that no action is required on their part.

Device

Recapper for the AutoMate 2500 Family. An in vitro diagnostic medical device (IVD).
  • Modelo / Serial
    Recapper for the AutoMate 2500 Family. An in vitro diagnostic medical device (IVD).ODL25250 AutoMate 2500ARTG Number: 177999
  • Manufacturer
    Beckman Coulter Australia Pty Ltd

Manufacturer

Beckman Coulter Australia Pty Ltd