Events

Rappel de Androstenedione assay run on Immulite, Immulite 1000, Immulite 2000, Immulite 2000XPi analysers. 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 Ltd Diagnostics Division.

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-2014-RN-00002-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2014-01-02
  • 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-2014-RN-00002-1
  • 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 over-recovery of samples with concentrations greater than 5.5ng/ml (19.2nmol/l) with the immulite/immulite 1000 and immulite 2000/ immulite 2000 xpi androstenedione assays. siemens has determined that these lots are linear up to a concentration of 5.5ng/ml (19.2nmol/l), instead of 10ng/ml (34.9nmol/l) as stated in the instructions for use (ifu). quality control materials at concentrations between 5.5ng/ml (19.2nmol/l) and 10ng/ml (34.9nmol/l) will detect this issue.
  • Action
    Siemens is advising their customers to use Quality Control materials with at least two levels having concentrations greater that 5.5ng/mL (19.2 nmols/L). Patient values of greater than 5.5ng/mL (19.2 nmols/L) should be verified using an alternate method.

Device

Androstenedione assay run on Immulite, Immulite 1000, Immulite 2000, Immulite 2000XPi analysers. ...
  • Modèle / numéro de série
    Androstenedione assay run on Immulite, Immulite 1000, Immulite 2000, Immulite 2000XPi analysers. An in vitro diagnostic medical device (IVD)Immulite/Immulite 1000Catalogue Number: LKA01Siemens Material Number: 10381158Lot Number: 409 and aboveImmulite 2000/Immulite 2000XPiCatalogue Number: L2KA02Siemens Material Number: 10381188Lot Number: 314 and aboveARTG Number: 179720
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

Siemens Ltd Diagnostics Division
  • Société-mère du fabricant (2017)
    Siemens AG
  • Source
    DHTGA