Events

Rappel de Bartels Herpes Simplex Virus Fluorescent Monoclonal Antibody Test. 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 Immuno 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-2014-RN-00742-1
  • Classe de risque de l'événement
    Class III
  • Date de mise en oeuvre de l'événement
    2014-07-07
  • 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-2014-RN-00742-1
  • 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
    As a result of an internal investigation by trinity biotech, it has been determined that the symbol to denote 'harmful' has been omitted from the package insert. the information within the package insert regarding tha handling and disposal of the product is still correct. if the package insert and msds is followed correctly there is no risk to the end user when handling or disposing of the kits.
  • Action
    Immuno is advising their customer that the product was supplied without the appropriate symbol to denote "Harmful". End users should be aware that all the information within the package insert is correct including handling and disposal instructions.

Device

Bartels Herpes Simplex Virus Fluorescent Monoclonal Antibody Test. An in vitro diagnostic medical...
  • Modèle / numéro de série
    Bartels Herpes Simplex Virus Fluorescent Monoclonal Antibody Test. An in vitro diagnostic medical device (IVD).Product code: B1029-47Lot number: C091009Expiry date: 17 March 2015
  • Manufacturer
    Immuno Pty Ltd

Manufacturer

Immuno Pty Ltd
  • Source
    DHTGA