Events

Rappel de Abbott RealTime High Risk HPV and RealTime High Risk (HR) HPV Application CD-ROM (for m2000 System)

Selon New Zealand Medicines and Medical Devices Safety Authority, ce/cet/cette rappel concerne un dispositif en/au/aux/à New Zealand qui a été fabriqué par Abbott Molecular Inc.

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
    15700
  • Date de mise en oeuvre de l'événement
    2013-11-21
  • Pays de l'événement
    New Zealand
  • Source de l'événement
    NZMMDSA
  • URL de la source de l'événement
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alertes
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Notes supplémentaires dans les données
    Recalling Organisation: Abbott Diagnostics Division, Ground Floor, Building D, 4 Pacific Rise, Mt Wellington, AUCKLAND 1640
  • Cause
    M2000rt instrument noise is defined as an unexpected cycle-to-cycle variability in the flurorescence signals during the amplification and detection process. abbott molecular has identified that the instrument noise lower limit validy parameter for the realtime hr hpv assay is set outside of the optinal setting to flag excess variability in fluroescence signal. therefore, in the presence of excess noise, incorrect results could be generated.
  • Action
    Software to be upgraded

Device

Abbott RealTime High Risk HPV and RealTime High Risk (HR) HPV Application CD-ROM (for m2000 System)
  • Modèle / numéro de série
    Model: List Numbers: 02N09 & 4N05-01, Affected: Version 1.0
  • Manufacturer
    Abbott Molecular Inc

Manufacturer

Abbott Molecular Inc
  • Société-mère du fabricant (2017)
    Abbott Laboratories
  • Commentaire du fabricant
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    NZMMDSA