Events

Rappel de DELFIA Xpress PlGF Kit

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-00629-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2015-07-14
  • 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-00629-1
  • 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
    Perkin elmer has become aware that the stability of the plgf calibrators lot 637341 is impaired. the stability issue is limited to one lot of plgf calibrators. due to the impaired stability a decreasing trend in the signal level measured for the plgf calibrators occurs; the signal level of the plgf calibrators lot 637341 has decreased an average of 20% since release. the signal decrease results in the measured plgf concentrations for the qc controls and patient samples will be falsely high, expected increase is approximately +20%. perkin elmer investigations have identified the impaired stability of the plgf calibrators is due to an issue in the quality of a single batch of the raw material used in the manufacture of the plgf calibrators.
  • Action
    Perkin Elmer is requesting the customers to check their inventory, immediately discontinue use and destroy all the affected DELFIA Xpress PlGF kit lots. PerkinElmer will replace all DELFIA Xpress PlGF Kits of the designated lots in the inventory. Perkin Elmer is further requesting the customers to review and repeat patient samples, if PlGF control values for completed DELFIA Xpress PlGF runs with the affected product lots are not within the established acceptance range. This action has been closed-out on 04/05/2017.

Device

DELFIA Xpress PlGF Kit
  • Modèle / numéro de série
    DELFIA Xpress PlGF Kit Catalogue numbers: 6007-002CProduct Lot numbers: 1063782701ARTG Number: 198244
  • Manufacturer
    PerkinElmer

Manufacturer

PerkinElmer