Events

Retiro De Equipo (Recall) de Spot-light Tissue Pre-treatment Kit (Antigen retrieval reagent used in cellular imaging). 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-2016-RN-01413-1
  • Clase de Riesgo del Evento
    Class III
  • Fecha de inicio del evento
    2016-11-01
  • 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-2016-RN-01413-1
  • 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
    It has been identified that the enzyme digestion reagent (reagent 2) contains 1.3x the normal amount of enzyme (pepsin) leading to excessive pepsinisation of cells. this may cause loss of tumour cell morphology and inadequate hybridization of fish/cish probes. the over pepsinisation will be obvious to the user when examining slides under a microscope.
  • Acción
    Life Technologies is advising users to dispose of affected stock. Credit will be issued for the affected stock. Unaffected stock is expected to be available from 31 November 2016. This action has been closed-out on 18/05/2017.

Device

Spot-light Tissue Pre-treatment Kit (Antigen retrieval reagent used in cellular imaging). An in v...
  • Modelo / Serial
    Spot-light Tissue Pre-treatment Kit (Antigen retrieval reagent used in cellular imaging). An in vitro diagnostic medical device (IVD).Catalogue Number: 008401Lot Numbers: 1667961A (exp. 31 Jul 2016), 1713166A (exp. 30 Nov 2016), 1714439A (exp. 30 Apr 2017), 1763308A (exp. 28 Feb 2018)ARTG Number: 212745
  • Manufacturer
    Life Technologies Australia Pty Ltd

Manufacturer

Life Technologies Australia Pty Ltd