Events

Retiro De Equipo (Recall) de IH-1000. 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 Bio-Rad Laboratories 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-00593-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2013-06-13
  • 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-00593-1
  • 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
    In some specific conditions, inconsistent grading between the results in the well/card and the results returned by the ih-1000 may be observed. in these very specific conditions, positive reactions might be read as negative by the system due to the analysis algorithm of the images. therefore this issue might lead to a wrong result released to the host if the 3 following conditions are met:1 a result is returned as negative while the reaction is positive, double population, or requires a human interpretation and, 2. this negative result is consistent with the global interpretation of the test and, 3. the system is configured without the second reading function activated for all tests results.
  • Acción
    Bio-Rad are providing work around instructions as an interim measure. A software update will be implemented to permanently correct the issue.

Device

IH-1000. An in vitro diagnostic medical device (IVD)
  • Modelo / Serial
    IH-1000. An in vitro diagnostic medical device (IVD)All software versions are affectedProduct reference: 001000ARTG Number: 184446
  • Manufacturer
    Bio-Rad Laboratories Pty Ltd

Manufacturer

Bio-Rad Laboratories Pty Ltd