Events

Retiro De Equipo (Recall) de D-10 Rack Loader. 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-2016-RN-00099-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-02-03
  • 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-2016-RN-00099-1
  • 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 is a potential for a sample and result to be mismatched when running in the d-10 rack loader configuration. this means that a patient result may be assigned to an incorrect sample id. while only two instances have been reported, bio-rad wants users to be aware of the possibility.
  • Acción
    Bio-Rad is investigating the reported issue and preparing a permanent solution. In the interim, users are advised to not skip positions within the rack. While reviewing results, check the Daily Summary for the following: A. Confirm that the number of results equals the total number of samples run. B. Confirm that injection numbers (I#) within an individual rack (R#) are consecutive. C. Confirm that any sample that was assigned an auto-generated Sample ID is actually missing a barcode label on the sample tube. Bio-Rad Laboratories will release a follow-up communication providing a permanent solution upon completion of a thorough investigation.

Device

D-10 Rack Loader. An in vitro diagnostic medical device (IVD).
  • Modelo / Serial
    D-10 Rack Loader. An in vitro diagnostic medical device (IVD).Catalogue Number: 220-0600ARTG Number: 212703
  • Manufacturer
    Bio-Rad Laboratories Pty Ltd

Manufacturer

Bio-Rad Laboratories Pty Ltd