Events

Rappel de ADVIA Centaur and ADVIA Centaur XP Immunoassay Systems (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-00925-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2014-08-22
  • 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-00925-1
  • 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 an issue that causes patient demographics data (patient name, age, sex) from the previous order received from the laboratory information system (lis) to be merged with the next order. this issue can occur when the lis data buffer on the advia centaur system becomes full and a particular character (h) is found in the last five locations in the lis data buffer. in this case, the incorrect patient demographic information will be transmitted to the lis and will be displayed on the advia centaur user interface and instrument generated printed reports.
  • Action
    If the ADVIA Centaur and / or ADVIA Centaur XP Immunoassay System is interfaced to a LIS system that transmits patient demographics with each order, the customers are advised to check the event log for the message: “500 03 01 Unknown format message” / rejected results on the LIS. If the message is present, customers are advised to review patient demographic information for all work orders after the time of this event to identify any specific ranges defined for age or sex apply to the order and ensure necessary action is taken for this result.

Device

ADVIA Centaur and ADVIA Centaur XP Immunoassay Systems (An in vitro diagnostic medical device (IVD))
  • Modèle / numéro de série
    ADVIA Centaur and ADVIA Centaur XP Immunoassay Systems (An in vitro diagnostic medical device (IVD))ADVIA Centaur Immunoassay SystemSiemens Material Number: Multiple ADVIA Centaur XP Immunoassay SystemSiemens Material Number: MultipleARTG Number: 175890
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

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