Events

Rappel de Vitamin D Total 100 Tests and Vitamin D Total 500 Tests (Used with ADVIA Centaur / ADVIA Centaur XP / ADVIA Centaur XPT Systems)

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 Healthcare Pty Ltd.

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-2016-RN-01351-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-10-17
  • 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-2016-RN-01351-1
  • 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 change in correlation between serum and plasma specimen tubes with the advia centaur vitamin d total assay as compared to instructions for use (ifu). the bias observed between serum and plasma samples has the potential to impact interpretation of vitamin d status in the event the patient's vitamin d level is at or near the cut-offs for deficient versus insufficient or insufficient versus sufficient. this may lead to the initiation of unnecessary vitamin d supplementation and/or additional monitoring of vitamin d levels.
  • Action
    Siemens is advising customers that they may continue to use the ADVIA Centaur Vitamin D Total assay with both serum and plasma specimen types, however, they should consider the bias when evaluating samples in different tube types. Siemens will contact customers when the updated Instructions For Use (IFU) is available for download from Siemens Doc Library.

Device

Vitamin D Total 100 Tests and Vitamin D Total 500 Tests (Used with ADVIA Centaur / ADVIA Centaur ...
  • Modèle / numéro de série
    Vitamin D Total 100 Tests and Vitamin D Total 500 Tests (Used with ADVIA Centaur / ADVIA Centaur XP / ADVIA Centaur XPT Systems)Catalogue/SMN Numbers: 10699201 and 10699533Kit Lots ending in:065 - Expiry: 09 Nov 2016066 - Expiry: 30 Jan 2017067 - Expiry: 11 Mar 2017068 - Expiry: 23 Apr 2017069 - Expiry: 21 Jul 2017070 - Expiry: 25 Aug 2017ARTG Number: 175700
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

Siemens Healthcare Pty Ltd
  • Société-mère du fabricant (2017)
    Siemens AG
  • Source
    DHTGA