Events

Rappel de IMMULITE 2000 and IMMULITE 2000 XPi - GI-MA (CA 19-9) Positive Bias

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-2015-RN-00131-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2015-02-18
  • 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-00131-1
  • 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 confirmed a positive bias with the bio-rad lyphochek tumor marker plus control and the bio-rad liquichek tumor marker control when used with immulite 2000/immulite 2000 xpi gi-ma (ca 19-9) assay kit lots 312 and 313.The bias in quality control values is the result of the introduction of a new lot of the bead coat antibody (murine monoclonal anti-ca 19-9 antibody) in kit lot 312. when comparing kit lot 312 with kit lot 311, siemens observed an average percent bias of 38% (ranging from 30% to 47%) for patient samples recovering from 29.6 to 44.4 u/ml and an average percent bias of 5% (ranging from 1% to 11%) for patient samples recovering from 540 to 660 u/ml.Future kit lots are expected to recover quality control and patient samples similar to kit lot 312.
  • Action
    Siemens is advising that patients may need to be re-base lined with kit lot 312 or higher. A look back over previously generated results should be discussed with the treating physician.

Device

IMMULITE 2000 and IMMULITE 2000 XPi - GI-MA (CA 19-9) Positive Bias
  • Modèle / numéro de série
    IMMULITE 2000 and IMMULITE 2000 XPi - GI-MA (CA 19-9) Positive BiasCatalogue number: L2KGI2Siemens Material Number: 10380988Lot numbers: 312 and 313ARTG number: 180780
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

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