Events

Retiro De Equipo (Recall) de Sysmex XN-550 Automated Haematology Analyser. 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 Roche Diagnostics Australia Pty Limited.

¿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-00485-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-05-04
  • 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-00485-1
  • 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
    Sysmex have found that that potentially inaccurate results could occur from improper mixing of a sample on the sysmex xn-550 automated haematology analyser with the following conditions:- the sample tube setup is for rbt micro collection tube or sarstedt sample tube, and- the xn-550 analyser is connected to a host computer and a host communication error occurs during a sampler run.If there is a sample tube located in the sample tube holder at this time, it will not be processed until the operator accepts the error message. sedimentation of the blood sample could occur during this time between error display and acceptance of the error, leading to potentially inaccurate results because the sample is processed without additional mixing. sysmex has found this issue is due to a software bug.
  • Acción
    Roche is advising users that this issue will be resolved in a software update that is expected to be released in May 2017 and will be installed by Roche personnel. Roche will contact users to arrange for the installation. In the interim, laboratories that use RBT micro collection tubes and/or Sarstedt sample tubes are advised to follow the directions provided in the customer letter when an error message related to a host communication and/or TCP/IP connection occurs.

Device

Sysmex XN-550 Automated Haematology Analyser. An in vitro diagnostic medical device (IVD)

Manufacturer

Roche Diagnostics Australia Pty Limited