Events

Rappel de Dade Innovin Reagent. An in vitro diagnostic medical device (IVD) (Prothrombin time 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-00873-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2014-09-12
  • 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-00873-1
  • 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 have identified that majority of current lots of this product are affected by reduced reagent stability after reconstitution.. affected lots were identified before release during regular quality control processes and became part of an extended testing program to verify reagent stability. there has been no impact on product performance within the reduced stability.
  • Action
    Siemens is advising end users that reduced in use stability claims will be indicated on a ‘Pink Note’ included with the kits. This action has been closed-out on 31/05/2016.

Device

Dade Innovin Reagent. An in vitro diagnostic medical device (IVD) (Prothrombin time assay)
  • Modèle / numéro de série
    Dade Innovin Reagent. An in vitro diagnostic medical device (IVD) (Prothrombin time assay)Affected lot numbers that have been supplied: 539267, 539267B, 539273, 539280, 539281, 539298, 539301, 539303A, 539305, 539306, 539309ARTG Number: 178501
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

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