Events

Rappel de ADVIA Centaur Systems, Dimension Vista Systems & IMMULITE Systems Estradiol Assays

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-2016-RN-00068-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2016-01-15
  • 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-2016-RN-00068-1
  • 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 diagnostics is conducting a correction for the certain estradiol products. it has been confirmed that the drug fulvestrant (faslodex) may cause falsely elevated estradiol results in the assays listed, which could lead the clinician to misinterpret the patient as pre-menopausal possibly leading to altered or discontinued use of the potential beneficial drug fulvestrant.The risk to health applies to all patients being treated with the drug fulvestrant.
  • Action
    Siemens’ Estradiol assays may continue to be used to report results for patients not on Fulvestrant therapy; these assays should not be used for patients being treated with Fulvestrant. For patients being treated with Fulvestrant, an alternate method such as LC-MS which is not expected to show cross reactivity to Fulvestrant should be used to measure Estradiol concentrations.

Device

ADVIA Centaur Systems, Dimension Vista Systems & IMMULITE Systems Estradiol Assays
  • Modèle / numéro de série
    ADVIA Centaur Systems, Dimension Vista Systems & IMMULITE Systems Estradiol AssaysADVIA Centaur Enhanced EstradiolCatalogue # and SMN: 10490889, 10491445, 10697757Dimension Vista LOCI EstradiolCat # K6463SMN: 10489099IMMULITE/ IMMULITE 1000 EstradiolCat #: LKE21, LKE21(D)SMN: 10381132, 10702832IMMULITE 2000 EstradiolCat #: L2KE22, L2KE22 (D), L2KE26, L2KE26 (D)SMN:10381178, 10702833, 10381177, 10702834All lots affectedARTG # 175698, 180109 and 179720
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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