Events

Retiro De Equipo (Recall) de Glucose-6-Phosphate Dehydrogenase. An in vitro diagnostic medical device (IVD).(quantitative kit used for determination of G-6-PDH in blood)

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-2017-RN-00081-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-01-31
  • 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-00081-1
  • 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
    The manufacturer, trinity biotech, has identified a potential for misdiagnosis with lot f117009. an investigation identified that this lot displays a level of accuracy variation outside the historical qc product release process control charts for normal range controls, despite falling within the qc acceptance specification. investigation testing has shown that there is objective evidence that the accuracy issue affects the normal patient range and not the deficient range with a potential health hazard of a false positive result (normal patient diagnosed as deficient) or an invalid test result occurring.
  • Acción
    Immuno is advising customers to immediately discontinue use of the affected lot and destroy any remaining product. Laboratories are to consider the need to review results previously generated with the affected lot. Immuno will organise replacement kits.

Device

Glucose-6-Phosphate Dehydrogenase. An in vitro diagnostic medical device (IVD).(quantitative kit ...
  • Modelo / Serial
    Glucose-6-Phosphate Dehydrogenase. An in vitro diagnostic medical device (IVD).(quantitative kit used for determination of G-6-PDH in blood)Product Code: 345ALot Number: F117009Expiry: 4 April 2018ARTG Number: 203621
  • Manufacturer
    Immuno Pty Ltd

Manufacturer

Immuno Pty Ltd
  • Source
    DHTGA