Events

Retiro De Equipo (Recall) de Lysercell WDF 2 x 4L used on Sysmex XN-Series Automated Haematology Analysers. 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-00159-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-02-01
  • 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-00159-1
  • 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
    Roche diagnostics australia has received several reports that lysercell wdf 2 x 4l lots a6028, a6029 and a6030 can lead to an increased occurrence (up to 3-fold) of the flag “blast/abn lympho?” . no other flags have been observed. this issue leads to an increase in the “blast/abn lympho?” flagging rate and unnecessary manual review. the risk of a misdiagnosis is mitigated by the fact that any flags observed from the affected instruments must be confirmed by a qualified morphologist using a manual blood film.
  • Acción
    Roche is advising customers to immediately discontinue use of and quarantine affected lots. New replacement lots will be provided by Roche.

Device

Lysercell WDF 2 x 4L used on Sysmex XN-Series Automated Haematology Analysers. An in vitro diagno...
  • Modelo / Serial
    Lysercell WDF 2 x 4L used on Sysmex XN-Series Automated Haematology Analysers. An in vitro diagnostic medical device (IVD).Material Number: 06510221001Lot Numbers: A6028, A6029, A6030ARTG Number: 188498
  • Manufacturer
    Roche Diagnostics Australia Pty Limited

Manufacturer

Roche Diagnostics Australia Pty Limited