Events

Rappel de VaccZyme Anti-Haemophilus Influenzae B Kit Code: MK016

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par In Vitro Technologies 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-2015-RN-00086-1
  • Classe de risque de l'événement
    Class III
  • Date de mise en oeuvre de l'événement
    2015-02-10
  • 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-2015-RN-00086-1
  • 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
    Possible visible and/or sub-visible microbial contamination of sample diluent was identified following a customer notification. internal testing has shown filtration of sample diluent using a 0.2 micron filter does not cause any significant change in performance of the diluent and therefore may be employed by the customer.
  • Action
    Internal testing by The Binding Site has shown that filtration of the sample diluent using a 0.2 micron filter does not cause any significant change in the performance of the diluent and therefore may be employed by the customer to remove the physical matter that may be present. It is strongly recommended that the filter and any alternative receptacles used are both as clean as possible in order to prevent any further potential for contamination of the product. This action has been closed-out on 03/08/2016.

Device

VaccZyme Anti-Haemophilus Influenzae B Kit Code: MK016
  • Modèle / numéro de série
    VaccZyme Anti-Haemophilus Influenzae B Kit Code: MK016Lot Numbers: 341492, 347294
  • Manufacturer
    In Vitro Technologies Pty Ltd

Manufacturer

In Vitro Technologies Pty Ltd