Events

Rappel de ADVIA Centaur Folate Assay

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-00369-1
  • Classe de risque de l'événement
    Class III
  • Date de mise en oeuvre de l'événement
    2014-03-28
  • 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-2014-RN-00369-1
  • 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 has confirmed one set of customer complaints related to the performance of the advia centaur systems folate assay, kit lots ending in 223. customers observed that the third party controls bio-rad liquichek and bio-rad lyphochek immunoassay plus folate serum controls may give rise to out of range low results with the advia centaur systems folate assay kits.In addition, siemens has confirmed a second set of customer complaints regarding a shift in whole blood patient results for advia centaur systems folate assay kit lots ending in 219 compared to kit lots ending in 222, 224, 225, 226 and 227.
  • Action
    Siemens is requesting their customers to discard all kit lots ending in 219 and 223 and to notify Siemens of any replacement needs. Kit lots ending in 222, 224, 225, 226, 227 and above can continue to be used as they provide accurate folate results.

Device

ADVIA Centaur Folate Assay
  • Modèle / numéro de série
    ADVIA Centaur Folate AssayLots Numbers Ending In/Expiration Date219 - 25 March, 2014223 - 12 May, 2014ARTG Number: 175700
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

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