Events

Retiro De Equipo (Recall) de Human IgM Kit for use on SPA Plus. 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 In Vitro Technologies 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-01157-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2013-11-15
  • 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-01157-1
  • 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
    Manufacturer investigations identified that the affected product may be subject to antigen excess effect; even though it's true value was below the claimed level of 56.4g/l. the antigen excess capacity of this product has been reviewed and has been confirmed as correct. investigations have suggested that the tested sample contained predominantly monoclonal igm and the manufacturer believes that this particular type of igm reacted aberrantly with the antibody and subsequently yielded this spurious result.
  • Acción
    In Vitro Technologies is advising end users of the issue and are updating the instructions for use to reflect the new performance information.

Device

Human IgM Kit for use on SPA Plus. An in vitro Diagnostic Medical Device (IVD)
  • Modelo / Serial
    Human IgM Kit for use on SPA Plus. An in vitro Diagnostic Medical Device (IVD)Product Codes: NK012.S & NK012.10SAll lot numbers affectedARTG Number: 202167
  • Manufacturer
    In Vitro Technologies Pty Ltd

Manufacturer

In Vitro Technologies Pty Ltd