Events

Rappel de ADVIA Chemistry XPT Systems with software version 1.0.3. 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-2015-RN-01049-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2015-10-28
  • 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-2015-RN-01049-1
  • 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 has identified multiple issues with the advia chemistry xpt systems with software version 1.0.3 that may affect the day to day behaviour and/or workflow of the system as follows:auto start-up failingcalibration interval resets when a reagent blank (rbl) is runcontrol definition screen assumes that the range is defined is 2 sd (standard deviation)laboratory information system (lis) communication / laboratory automation (las) issueprinter driver resetsise calibration ranges are too conservative for urine sodium (na)archiving and deletion may failworkstation services may restartwith the alerts generated by the instrument for the scenarios impacting samples, the operator will be aware that a sample may not have been processed and can take action. calibration and control issues are detectable through normal laboratory monitoring practices.
  • Action
    All the issues above except (Issue: Workstation services may restart) are corrected in software version 1.1 which is now available for installation on affected systems. The temporary actions defined in the customer letter should be undertaken until the affected systems have been upgraded to software version 1.1. The remaining issue will be corrected in a future software version.

Device

ADVIA Chemistry XPT Systems with software version 1.0.3. An in vitro diagnostic medical device (IVD)
  • Modèle / numéro de série
    ADVIA Chemistry XPT Systems with software version 1.0.3. An in vitro diagnostic medical device (IVD)Siemens Material Number (SMN): 10723034ARTG Number: 175890
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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