Events

Retiro De Equipo (Recall) de UniCel DxH 600 & 800 Coulter Cellular Analysis 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 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-01651-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-12-23
  • 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-01651-1
  • 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 determined that additional clarification for the blast suspect messages is necessary. in certain situations, the unicel dxh 800 and dxh 600 coulter cellular analysis system may not flag or detect blasts in some blood samples. this is due to limitations in the available technology as well as sample limitations. in these situations there could be a delay in the diagnosis and treatment of conditions associated with blasts in the peripheral blood.
  • Acción
    Beckman Coulter is providing users with information about limitations of the of the UniCel DxH 600 & 800 systems with respect to the flagging and detection of blasts in some blood samples. Detailed information will be provided in a customer letter and will also be temporarily available within the online ReadMefile, B44444AE, available on the Beckman Coulter website. Revised instructions that include this information will be available in March 2017. The information provided should be discussed with the Medical Director with respect to looking-back of previous patient results. In addition, the possibility of false negatives and the need for blood films should be considered.

Device

UniCel DxH 600 & 800 Coulter Cellular Analysis Systems. An in vitro diagnostic medical device (IVD).
  • Modelo / Serial
    UniCel DxH 600 & 800 Coulter Cellular Analysis Systems. An in vitro diagnostic medical device (IVD).UniCel DxH 800 Reference Number: 629029, B24465, B24802, B68304UniCel DxH 600 Reference Number: B23858All software versionsARTG Number: 177999
  • Manufacturer
    Beckman Coulter Australia Pty Ltd

Manufacturer

Beckman Coulter Australia Pty Ltd