Events

Rappel de ADVIA Centaur & ADVIA Centaur XP Immunoassay 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 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-00910-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2014-08-20
  • 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-00910-1
  • 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 an urgent recall for product correction for the advia centaur and advia centaur xp immunoassay systems, regarding manually loaded sample racks that are improperly loaded or pushed too far on the sample entry queue during normal operation of the advia centaur and advia centaur xp immunoassay systems. pushing the sample racks may cause misreads of sample ids (sid) if the sample rack loading instructions are not followed exactly as described in the advia centaur or advia centaur xp operator’s guide.If a sample rack is manually pushed with a slight forward nudge to the entry position without placing it on the rack positioning guide, the barcoded tube sid can be assigned to different positions in the rack. this may lead to misreported results.
  • Action
    Siemens Healthcare Diagnostics is advising the customers that when loading a sample rack, the user must ensure that the sample rack notch rests on the raised area of the sample entry queue and the system automatically moves the rack to the loading position. The raised guide ensures the sample rack is positioned correctly and will accurately scan each barcode as it enters the inprocess queue. Users are further advised not to push the sample racks into the system. During the next service visit, Siemens Healthcare Diagnostics service engineers will affix a label stating "Do not push sample rack" onto the system to reinforce the proper loading technique of the sample rack. This action has been closed-out on 5/08/2016.

Device

ADVIA Centaur & ADVIA Centaur XP Immunoassay System (An in vitro diagnostic medical device (IVD))
  • Modèle / numéro de série
    ADVIA Centaur & ADVIA Centaur XP Immunoassay System (An in vitro diagnostic medical device (IVD))ADVIA Centaur Immunoassay SystemSiemens Material Number: Multiple ADVIA Centaur XP Immunoassay SystemSiemens Material Number: MultipleAll Serial Numbers ARTG number: 174383
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

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