Events

Retiro De Equipo (Recall) de Foetal Haemoglobin Monoclonal Antibody (HBF-1). 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-2017-RN-01414-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-11-15
  • 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-2017-RN-01414-1
  • 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 australia have received four (4) customer complaints worldwide on multiple lots pertaining to poor antibody detection whereby customers reported little to no antibody staining. in the complaints received, customers identified a reduction in the intensity of staining, unequal staining, and in some instances, may have observed a reduction or shift in the positive population peak for foetal haemoglobin. with the use of controls, the end user can identify a product deficiency before diagnostic samples are analysed. failure of the positive controls to perform as expected is a basis for discarding test results and repeating the test.There have been no reports of injuries as a result of this issue.
  • Acción
    Life Technologies is advising users to inspect stock and discard any remaining units of the affected lot number. There is unaffected stock available.

Device

Foetal Haemoglobin Monoclonal Antibody (HBF-1). An in vitro diagnostic medical device (IVD)
  • Modelo / Serial
    Foetal Haemoglobin Monoclonal Antibody (HBF-1). An in vitro diagnostic medical device (IVD) Catalogue Number: MHFH01Lot Number: 1848553AExpiry date: 31 January 2019ARTG Number: 212744
  • Manufacturer
    Life Technologies Australia Pty Ltd

Manufacturer

Life Technologies Australia Pty Ltd