Events

Rappel de TREPANOSTIKA TP Recombinant Kit (An in vitro diagnostic medical device (IVD) used for the qualitative determination of specific antibodies to Syphilis (treponema pallidum) in human serum or plasma)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Biomerieux 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-2013-RN-00174-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2013-02-25
  • 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-2013-RN-00174-1
  • 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
    Following customer complaints on out of range negative control, biomérieux investigation has confirmed an issue with some lots of trepanostika™ tp recombinant related to the aluminium bag that contains the microelisa strip plates. the impacted strips may contain bad aluminium bags, or a mixture of good and bad aluminium bags. as a result, customers may either experience false results or negative control out of range.
  • Action
    Biomereiux is asking customers to stop using the affected lot and discard them.

Device

TREPANOSTIKA TP Recombinant Kit (An in vitro diagnostic medical device (IVD) used for the qualita...
  • Modèle / numéro de série
    TREPANOSTIKA TP Recombinant Kit (An in vitro diagnostic medical device (IVD) used for the qualitative determination of specific antibodies to Syphilis (treponema pallidum) in human serum or plasma)Product Code: 285035Lot: D33GAExpiry: 2013-07-28
  • Manufacturer
    Biomerieux Australia Pty Ltd

Manufacturer

Biomerieux Australia Pty Ltd