Events

Retiro De Equipo (Recall) de IH-Com Kit Full version (Data management and Result Interpretation Software for ABO blood grouping). An in vitro diagnostic medical device (IVD)Used for ABO Blood GroupingAn 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-2012-RN-01215-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2012-11-30
  • 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-2012-RN-01215-1
  • 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
    There have been reports of results not being interpreted in the anti-ab well (abo3) of id-cards intended for abo forward grouping, the ih-com software doesn't include the reaction of this well when sending the result to the laboratory host (result code-30).This can occur in the following situations;1. ih-com software is connected to the laboratory host through astm communication mode, and2. an "abo not interpretable" result is obtained due to a reaction "?" or "+-" or "dp" in the anti-ab well of the id-card intended for abo forward grouping, and3. the "second reading" option is deactivated and ih-com results are directly sent to the host, or4. the "second reading" option is activated by the the "not interpretable" result is obtained in ih-com directly saved and sent to host without a manual selection by the user in abo scrollbar.
  • Acción
    Bio-Rad Laboratories will be providing work around instructions in the customer letter. A software update will be implemented to correct the problem.

Device

IH-Com Kit Full version (Data management and Result Interpretation Software for ABO blood groupin...
  • Modelo / Serial
    IH-Com Kit Full version (Data management and Result Interpretation Software for ABO blood grouping). An in vitro diagnostic medical device (IVD)Used for ABO Blood GroupingAn in vitro diagnostic medical device (IVD)
  • Manufacturer
    Bio-Rad Laboratories Pty Ltd

Manufacturer

Bio-Rad Laboratories Pty Ltd