Events

Rappel de LifeCycle for Prenatal Screening software

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-2015-RN-00999-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2015-10-13
  • 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-2015-RN-00999-1
  • 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 issue was caused by an unintended rounding of the median equation factors that led to inadequate number of significant digits (decimals) in the default median equation. the equation was originally introduced in lifecycle version v4.0 rev4. due to the issue, the inhibin a mom level of an unaffected population was observed to be approximately half from what it should have been. this unintended rounding error was observed internally and no customer complaints have been received.
  • Action
    Perkin Elmer is providing users with instructions to correct the error. Alternatively, Perkin Elmer can implement the correction at the affected site. This action has been closed-out on 19/08/2016.

Device

LifeCycle for Prenatal Screening software
  • Modèle / numéro de série
    LifeCycle for Prenatal Screening softwareCatalogue Number: 5014-0020 Version Number: v4.0 Rev4ARTG Number: 216895
  • Manufacturer
    PerkinElmer

Manufacturer

PerkinElmer