Events

Rappel de LifeCycle for Prenatal Screening v4.0, v4.0 Rev 2 and v4.0 Rev 3. 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-2015-RN-00452-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2015-05-27
  • 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-00452-1
  • 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
    Wallac oy, a subsidiary of perkinelmer, has become aware that lifecycle for prenatal screening (5014-0020) may generate an incorrect risk calculation result for twins if lifecycle v4.0 risk calculation protocol is used and a particular sequence of actions occur.The issue is related to chorionicity correction of twins, which can be applied only with biomarker results for hcgb, papp-a and plgf in 1st trimester. if a second sample (e.G. 2nd trimester or dvpi examination) is attached to the same case, the moms should be cleared in order to recalculate the moms without chorionicity correction. if there are no gestational age calculation changes made, the 1st trimester sample moms will remain. since 1st trimester moms are chorionicity corrected when chorionicity is given, the mom values are too low resulting in unexpected risk values. if close to cut-off, a true risk value might end up on the opposite side of the cut-off and be reported as opposite risk result.
  • Action
    Customers are advised that if they are using the affected software version and follow the sequence of actions that will result in the above issue, they should ensure that the MoM’s for hCGb, PAPP-A and PlGF biomarkers are always cleared before recalculating the risk when a second sample is added to the same case. This can be achieved by clearing the chorionicity information and saving the case data. PerkinElmer has developed a Database Investigation Script that can be used to determine if any affected calculations exists in customer’s LifeCycle database. Any decisions regarding the need to reassess/recalculate previously reported risk value results should be made on a case by case basis. Software v4.0 Rev 4 is under development and will correct this issue. Customers will be notified when the software update is available and it will be provided to them free of charge. This action has been closed-out on 11/08/2016.

Device

LifeCycle for Prenatal Screening v4.0, v4.0 Rev 2 and v4.0 Rev 3. An in vitro diagnostic medical ...
  • Modèle / numéro de série
    LifeCycle for Prenatal Screening v4.0, v4.0 Rev 2 and v4.0 Rev 3. An in vitro diagnostic medical device (IVD)Catalogue number: 5014-0020ARTG Number: 216895
  • Manufacturer
    PerkinElmer

Manufacturer

PerkinElmer