Events

Retiro De Equipo (Recall) de Bartels Herpes Simplex Virus Fluorescent Monoclonal Antibody Test. 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 Immuno 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-2014-RN-00742-1
  • Clase de Riesgo del Evento
    Class III
  • Fecha de inicio del evento
    2014-07-07
  • 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-2014-RN-00742-1
  • 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
    As a result of an internal investigation by trinity biotech, it has been determined that the symbol to denote 'harmful' has been omitted from the package insert. the information within the package insert regarding tha handling and disposal of the product is still correct. if the package insert and msds is followed correctly there is no risk to the end user when handling or disposing of the kits.
  • Acción
    Immuno is advising their customer that the product was supplied without the appropriate symbol to denote "Harmful". End users should be aware that all the information within the package insert is correct including handling and disposal instructions.

Device

Bartels Herpes Simplex Virus Fluorescent Monoclonal Antibody Test. An in vitro diagnostic medical...
  • Modelo / Serial
    Bartels Herpes Simplex Virus Fluorescent Monoclonal Antibody Test. An in vitro diagnostic medical device (IVD).Product code: B1029-47Lot number: C091009Expiry date: 17 March 2015
  • Manufacturer
    Immuno Pty Ltd

Manufacturer

Immuno Pty Ltd
  • Source
    DHTGA