Events

Rappel de Various Microgenics Application Sheets. 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 Thermo Fisher Scientific Australia Pty Ltd.

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-2017-RN-00692-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-06-14
  • 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-2017-RN-00692-1
  • 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
    During an internal assessment, thermo fisher scientific found that application sheets provided by the manufacturer microgenics for expanded use of some assays are inadequate. specifically, the appropriate validation data for the expanded use of these assays, as indicated in the instructions for use (ifu) when not used on manufacturer approved analysers, is inadequate. in addition, microgenics did not clearly state in these application sheets that the parameters provided are only to be used as starting points and that each assay setting needs to be validated individually by the user.Thus the information given on the specific application sheets for use with non-microgenics approved analysers may be ineffective. it is possible that assays not validated for use with other instrument platforms could potentially lead to erroneously low or high test results.
  • Action
    Thermo Fisher Scientific is requesting users to 1) immediately discontinue use of the affected application sheets used on their specific instrument platform, 2) review their internal assay validations to determine if their current instrument settings using these assays require additional action within their clinical laboratory settings (consult a qualified healthcare professional, as appropriate) and 3) contact Customer Service to check if additional action is required.

Device

Various Microgenics Application Sheets. An in vitro diagnostic medical device (IVD)
  • Modèle / numéro de série
    Various Microgenics Application Sheets. An in vitro diagnostic medical device (IVD)Multiple Assays / Instrument PlatformsARTG Numbers: 192621 and 235822
  • Manufacturer
    Thermo Fisher Scientific Australia Pty Ltd

Manufacturer

Thermo Fisher Scientific Australia Pty Ltd