Events

Rappel de IMMULITE/IMMULITE 1000 IMMULITE 2000/IMMULITE 2000 XPi Assays. 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 Siemens Healthcare 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-01516-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-12-18
  • 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-01516-1
  • 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
    Siemens healthcare has confirmed through internal investigation that certain immulite/immulite 1000/immulite 2000/immulite 2000 xpi assays are susceptible to biotin interference. this occurs when biotin present in patient samples interferes with the biotin-streptavidin assay architecture on the immulite platform. biotin interference has the potential to bias analytical results of the affected assays. the instructions for use (ifu) currently do not list biotin as a potential interferant.Concentrations of biotin above the determined concentration can potentially result in interference greater than 10%, leading to either falsely elevated or falsely depressed results. cea, folic acid, om-ma (ca125) and vitamin b12 exhibited falsely elevated results with the determined biotin concentrations.3gallergy specific ige, anti hbc, br-ma (ca15-3), ck-mb, epo, gastrin and thyroglobulin exhibited falsely depressed results with determined biotin concentrations.
  • Action
    Siemens is providing users with updated information regarding biotin interference and updating the Instructions for Use (IFU).

Device

IMMULITE/IMMULITE 1000 IMMULITE 2000/IMMULITE 2000 XPi Assays. An in vitro diagnostic medical dev...
  • Modèle / numéro de série
    IMMULITE/IMMULITE 1000 IMMULITE 2000/IMMULITE 2000 XPi Assays. An in vitro diagnostic medical device (IVD)Affected Multiple Assay Numbers, Catalogue Numbers and Material NumbersARTG: 179719, 180780, 180969, 179720, 179721
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

Siemens Healthcare Pty Ltd
  • Société-mère du fabricant (2017)
    Siemens AG
  • Source
    DHTGA