Events

Rappel de Osteocalcin assay run on IMMULITE 2000 & IMMULITE 2000 XPi analysers. 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-00036-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2014-01-20
  • 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-00036-1
  • 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 under recovery up to 50% in patient values across the assays reportable range with the affected immulite 2000/immulite 2000 xpi osteocalcin (l2kon2) kit lots. quality control materials will not detect the bias.Osteocalcin can serve as a measure of increased bone resorption in some patient. depending upon the treatment approach, the measurement of osteocalcin may correlate to therapy. in some patients risk of osteoporosis correlates of increasing values of osteoclacin.
  • Action
    Siemens Healthcare is advising users to discontinue and discard affected lots. Siemens does not currently have a replacement for this product. Siemens is recommending discussing this notice with the medical director regarding the need to review previous test results, conduct patient follow and / or repeat testing for patients tested with the affected lots.

Device

Osteocalcin assay run on IMMULITE 2000 & IMMULITE 2000 XPi analysers. An in vitro diagnostic medi...
  • Modèle / numéro de série
    Osteocalcin assay run on IMMULITE 2000 & IMMULITE 2000 XPi analysers. An in vitro diagnostic medical device (IVD)Test Code: OCNCatalogue Number: L2KON2Lot Numbers: 218, 219, 220 & 221Siemens Material Number: 10381477ARTG Number: 179720
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

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