Events

Retiro De Equipo (Recall) de HemoCue WBC Diff analysers and WBC Diff Microcuvettes. 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 Radiometer Pacific 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-2018-RN-00161-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2018-03-19
  • 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-2018-RN-00161-1
  • 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
    No specific limitations are given in the indications for use for the system. however, hemocue has become aware that there is a need to clarify that use of the hemocue wbc diff system on patients on chemotherapy, other immunosuppressive therapies or on drugs with immunosuppressive effects, has not been fully evaluated by hemocue ab.Riskif incorrect results are obtained for these patient populations it could potentially lead to a delay in a dose modification and increased infection risk.Hemocue will be updating the instruction for use for the wbc diff system to include the above clarification.
  • Acción
    Radiometer will be providing updated instructions for use to provide clarification regarding the use of the HemoCue WBC Diff system on patients on chemotherapy, other immunosuppressive therapies or on drugs with immunosuppressive effects.

Device

HemoCue WBC Diff analysers and WBC Diff Microcuvettes. An in vitro diagnostic medical device (IVD)
  • Modelo / Serial
    HemoCue WBC Diff analysers and WBC Diff Microcuvettes. An in vitro diagnostic medical device (IVD)All Serial NumbersARTG Numbers: 222568, 222701(Radiometer Pacific - Haematology full blood count IVDs)
  • Manufacturer
    Radiometer Pacific Pty Ltd

Manufacturer

Radiometer Pacific Pty Ltd