Events

Rappel de ADVIA Chemistry Theophylline_2 Reagent

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-00831-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-06-27
  • 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-00831-1
  • 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 identified that the advia chemistry theophylline_2 (theo_2) reagent lot 334018 used on the advia 1200, 1800, 2400, and xpt chemistry systems may exhibit increased imprecision for commercially available tdm quality controls and patient specimens.Siemens internal investigation after one internal complaint was received confirmed that reagent lot 334018 is not in statistical alignment with the representative precision data published in the ifu and the design input requirements on the advia chemistry systems.Discordance with the clinical presentation is expected to lead to repeat testing or more frequent monitoring. there may be a delay in theophylline testing due to troubleshooting after failed qc.
  • Action
    Siemens is advising users to discontinue use of and discard the kit lot. Siemens is recommending that a review of previously generated results is considered.

Device

ADVIA Chemistry Theophylline_2 Reagent
  • Modèle / numéro de série
    ADVIA Chemistry Theophylline_2 ReagentTest Code: THEO_2Catalogue Number: 10377503Lot Number: 334018Expiration Date: Sept 2017ARTG Number: 175699An in vitro diagnostic medical device (IVD)
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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