Events

Retiro De Equipo (Recall) de Foetal Haemoglobin Monoclonal Antibody (HBF-1), FITC. 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 Life Technologies Australia 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-2018-RN-00125-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2018-02-07
  • 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-2018-RN-00125-1
  • 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
    Life technologies has become aware of a performance issue where the specific lots of foetal haemoglobin monoclonal antibody are displaying high or unusually bright background which could potentially lead to erroneous(false positive) results.
  • Acción
    Life Technologies is advising users to discard any remaining product of the affected lot. A product hold has been placed on future stock, and a credit will be provided for all affected stock. A review of previously generated test results should be performed at the discretion of the laboratory Director.

Device

Foetal Haemoglobin Monoclonal Antibody (HBF-1), FITC. An in vitro diagnostic medical device (IVD)
  • Modelo / Serial
    Foetal Haemoglobin Monoclonal Antibody (HBF-1), FITC. An in vitro diagnostic medical device (IVD)Catalogue Number: MHFH01Lot Number: 1626670DExpiry Date: 30/04/2018ARTG Number: 212744 - (Life Technologies Australia - Haemoglobin IVD)
  • Manufacturer
    Life Technologies Australia Pty Ltd

Manufacturer

Life Technologies Australia Pty Ltd