Events

Rappel de The Binding Site SPAPLuS analyser. 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 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-2014-RN-00150-1
  • Classe de risque de l'événement
    Class III
  • Date de mise en oeuvre de l'événement
    2014-02-11
  • 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-00150-1
  • 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
    In vitro technologies have been notified by the manufacturer that the “prog error (overflow) det comm” pop-up message has been recently reported on a number of the spaplus analysers with the ‘c’ suffix on the serial number. when the error occurs, analysis will stop and a full shutdown is required to restart testing. in addition to this, it causes results to be lost and the test will be required to be repeated.
  • Action
    In Vitro Technologies are advising users that a build up of static is the cause of the issue. A grounding unit will be installed on all affected units to prevent the error from occurring.

Device

The Binding Site SPAPLuS analyser. An in vitro diagnostic medical device (IVD)
  • Modèle / numéro de série
    The Binding Site SPAPLuS analyser. An in vitro diagnostic medical device (IVD)All serial numbers with ‘C’ suffix Catalogue number: TBSIE610ARTG Number: 201723
  • Manufacturer
    In Vitro Technologies Pty Ltd

Manufacturer

In Vitro Technologies Pty Ltd