Events

Rappel de ADVIA Centaur Folate ReadyPack, Lot 071218 Kit Lots (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-2013-RN-00778-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2013-07-30
  • 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-2013-RN-00778-1
  • 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 that a portion of folate readypacks in kit lots ending in 218 are exhibiting calibration failures and/or significant negative shifts in quality control (qc) and patient results. if the calibration and qc on a readypack are valid, results generated with this readypack are not affected. however, due to the sporadic nature of the issue, successful calibration and qc on one readypack may not reflect acceptable performance of other readypacks in the lot.
  • Action
    If a customer has an alternative method or lot of ADVIA Centaur Folate, Siemens Healthcare is advising users to transition all folate testing to the alternative lot or method. Siemens Healthcare is providing users with work around instructions to follow with the affected product. The Laboratory Medical Director should determine if repeat testing of patient samples that demonstrated results below the reference interval is appropriate.

Device

ADVIA Centaur Folate ReadyPack, Lot 071218 Kit Lots (an in vitro diagnostic medical device (IVD))
  • Modèle / numéro de série
    ADVIA Centaur Folate ReadyPack, Lot 071218 Kit Lots (an in vitro diagnostic medical device (IVD))ADVIA Centaur Folate (100 tests)Kit Lot Numbers: 22288218, 22296218 & 22907218ADVIA Centaur Folate (500 tests)Kit Lot Numbers: 22289218, 22297218 & 22535218ADVIA Centaur Folate (500 tests)Kit Lot Number: 22298218ADVIA Centaur Folate (2500 tests)Kit Lot Number: 22299218Expiration Date: 17 Feb 2014ARTG Number:175700
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

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