Events

Retiro De Equipo (Recall) de LH 750 and LH 780 Haematology 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-2013-RN-01284-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2013-12-02
  • 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-2013-RN-01284-1
  • 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
    Update: beckman coulter's investigation has shown that the lh cleaner and coulter clenz was the main contributor to the optical degradation issue.Complaints related to optical degradation have increased on the lh 750 and lh 780 haematology systems. customers have reported an increase in ls offset error messages during startup, background, control and/or patient analysis.The optical degradation may potentially cause a delay in reporting results for nucleated red blood cells, white blood cell differential and/or reticulocytes.Cbc panel results are available for reporting and are not affected by this issue.
  • Acción
    Update: Beckman Coulter is requesting their customers to discard the affected lot of LH Cleaner. Laboratories can discontinue the additional Clear Flow Cell and Extended Cleaning actions. Beckman Coulter is recommending users perform a Clear Flow Cell and Extended Cleaning and perform a routine shutdown at least daily. Beckman Coulter is investigating this issue further in order to provide a permanent fix.

Device

LH 750 and LH 780 Haematology System. An in vitro diagnostic medical device (IVD)
  • Modelo / Serial
    LH 750 and LH 780 Haematology System. An in vitro diagnostic medical device (IVD)LH 750 Haematology SystemPart Numbers 6605632 and A85570LH 780 Haematology System Part Numbers 723585 and A90728
  • Manufacturer
    Beckman Coulter Australia Pty Ltd

Manufacturer

Beckman Coulter Australia Pty Ltd