Events

Rappel de LifeCycle for Prenatal Screening software. 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 PerkinElmer.

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-00843-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2013-08-13
  • 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-00843-1
  • 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
    The manufacturer has become aware of an unexpected behaviour in how the lifecycle risk calculation engine (elipse) accepts and utilizes the ethnic factor given by the user. if the ethnic factor has been changed from a valid numeric value to "0" (zero) the case risk will not be calculated by applying the latest validated median equation as intended by the user.
  • Action
    PerkinElmer is advising users to replace the default median equations supplied at installation with laboratory-specific ones and maintain the Marker Medians-form to ensure the Ethnic Factor values are greater than zero. PerkinElmer are recommending users update the software to version 4.0 rev 2. A review of past results should be made on a case by case bases as recommended by PerkinElmer.

Device

LifeCycle for Prenatal Screening software. An in vitro diagnostic medical device (IVD).
  • Modèle / numéro de série
    LifeCycle for Prenatal Screening software. An in vitro diagnostic medical device (IVD).Catalogue numbers: 5002-0020Software version: v2.1, v2.2, v3.0, v3.1, v3.2 (including all revisions)
  • Manufacturer
    PerkinElmer

Manufacturer

PerkinElmer