Events

Retiro De Equipo (Recall) de UniCel DxH 600 and DxH800 Coulter Cellular Analysis System. 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-01093-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-08-19
  • 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-01093-1
  • 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 the possibility of specimen mis-identification for the stand-alone dxh 800 and dxh 600 where the primary identifier is configured to tube position id. this issue does not occur if the primary identifier is configured as specimen id. results from a patient control sample could be misidentified by being associated with a pending test order for a patient sample already on the worklist when the following sequence of events occurs:- the primary identifier is tube position id.- a patient control file is setup for id xxxxx, and a pending test order for a patient sample id xxxxx is subsequently added to the worklist.- the patient control sample is analysed using cassette presentation, but that tube does not contain a barcode-labelled specimen id or the label cannot be read.Upon analysis, the results from the analysed patient control tube will be associated with the patient sample that was pending on the worklist and not the patient control file.
  • Acción
    Beckman Coulter is advising users to ensure there are no pending or active test orders in the worklist before analysing a patient control with a Tube Position ID. Beckman Coulter is investigating the issue in order to determine a resolution.

Device

UniCel DxH 600 and DxH800 Coulter Cellular Analysis System. An in vitro diagnostic medical device...
  • Modelo / Serial
    UniCel DxH 600 and DxH800 Coulter Cellular Analysis System. An in vitro diagnostic medical device (IVD)UniCel DxH 600Reference Numbers: 629029, B24465, B24802, B68304 UniCel DxH 800Reference Number: B23858 All software versionsARTG Number: 177999
  • Manufacturer
    Beckman Coulter Australia Pty Ltd

Manufacturer

Beckman Coulter Australia Pty Ltd