Events

Rappel de LifeCycle for Prenatal Screening, software versions V3.0, v3.1, v3.2, v4.0. 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-00125-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2013-02-13
  • 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-00125-1
  • 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 that lifecycle for prenatal screening may generate an incorrect risk calculation with ivf (in vitro fertilisation) screening cases. the problem occurs if the user enters data incorrectly in combination with a specific series of events as described below:· the user initially enters the mother’s birth date (dob) incorrectly for an ivf case, and calculates the risk using the incorrect dob· the user recognises the dob entry error, corrects the error by entering the correct dob and recalculates the risk · lifecycle does not utilise the corrected dob, and recalculates the risk using the initial, incorrect dob · lifecycle generates an incorrect risk calculation for the ivf screening case.
  • Action
    The LifeCycle issue can be corrected by either upgrading to LifeCycle software version v4.0 Rev2, or by implementing dedicated software Service Pack (LifeCycle Service Pack 12-03c) to resolve the problem. End users are recommended to choose one of the two options and the software upgrade will be provided free of charge.

Device

LifeCycle for Prenatal Screening, software versions V3.0, v3.1, v3.2, v4.0. An in vitro diagnosti...
  • Modèle / numéro de série
    LifeCycle for Prenatal Screening, software versions V3.0, v3.1, v3.2, v4.0. An in vitro diagnostic medical device (IVD)Catalogue Numbers: 5002-0020, 5014-0020
  • Manufacturer
    PerkinElmer

Manufacturer

PerkinElmer