Events

Rappel de Spot-light Tissue Pre-treatment Kit (Antigen retrieval reagent used in cellular imaging). An in vitro diagnostic medical device (IVD).

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Life Technologies Australia Pty Ltd.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    RC-2016-RN-01413-1
  • Classe de risque de l'événement
    Class III
  • Date de mise en oeuvre de l'événement
    2016-11-01
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01413-1
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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.
  • Action
    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...
  • Modèle / numéro de série
    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