Events

Rappel de Methotrexate Assay performed on Syva Emit Methotrexate Application (DVMTX.1) for the Dimension Vista System. 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-2016-RN-00332-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-03-21
  • 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-00332-1
  • 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 has identified that the syva emit methotrexate application for the dimension vista system does not meet the on-board stability claim of 20 hours. internal testing using reagent at the end of the 20 hour on-board stability has shown that values of methotrexate for patient and quality control samples increased.The observed bias for patient and qc samples measured within the first 4 hours of the on-board stability was < 10%. if users have run methotrexate patient samples and qc in batch, qc can detect the issue. the risk to health as a result of this issue is limited to patient samples that are not run with quality control once reagents have been on-board the instrument for >4 hours. when this issue occurs, the potential exists to report falsely elevated methotrexate concentrations and to consider adjustment of folinic acid administration.
  • Action
    Siemens is recommending that laboratories retest methotrexate samples that were run within the previous 24 hours where the following criteria are met: (1) Samples were run without Quality Control >4 hours after reagent was loaded on the instrument, and (2) Samples are within the specified storage conditions and time. Siemens is withdrawing the Emit Methotrexate Application on the Vista system and can advise users of alternative testing methods for methotrexate. Siemens is recommending users change the On-board stability for the methotrexate application to four hours, or run in batch mode with QC. This action has been closed-out on 16/05/2017.

Device

Methotrexate Assay performed on Syva Emit Methotrexate Application (DVMTX.1) for the Dimension Vi...
  • Modèle / numéro de série
    Methotrexate Assay performed on Syva Emit Methotrexate Application (DVMTX.1) for the Dimension Vista System. An in vitro diagnostic medical device (IVD)Catalogue Number: 6L119ULSiemens Material Number (SMN): 10445368All lot numbers affectedARTG Number: 182220
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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