Events

Retiro De Equipo (Recall) de Polymer Refine Red Detection (used for testing and identification of neoplasm). 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 Leica Biosystems Melbourne 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-2015-RN-01206-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-12-08
  • 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-2015-RN-01206-1
  • 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
    Leica biosystems recently became aware that some detection kits may have been subject to a manufacturing error where some containers were under-filled and topped up with the incorrect reagent, leading to inadequate staining. if the product is used according to the instructions for use with the adequate controls, the end user would be able to identify the test has not stained correctly.
  • Acción
    Leica Biosystems is advising users to discontinue use of the affected lot numbers and destroy any remaining stock. Leica Biosystems is recommending consulting with the Laboratory Director and Physician to determine if a review of past results is warranted. This action has been closed-out on 29/08/2016.

Device

Polymer Refine Red Detection (used for testing and identification of neoplasm). An in vitro diagn...
  • Modelo / Serial
    Polymer Refine Red Detection (used for testing and identification of neoplasm). An in vitro diagnostic medical device (IVD)Product Code: DS9390Lot Number: 41872 Expiry date: November 2016ARTG Number: 211376
  • Manufacturer
    Leica Biosystems Melbourne Pty Ltd

Manufacturer

Leica Biosystems Melbourne Pty Ltd