Events

Rappel de Siemens Capillary Caps for RAPIDLyte Multicap and Multicap-S Blood Collection Capillaries(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-2015-RN-00084-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2015-01-30
  • 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-2015-RN-00084-1
  • 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 a material change made by the supplier has resulted in capillary caps that are more difficult to apply to the capillaries. attempting to apply these capillary caps to the capillaries could result in spillage of the sample or possible breakage of the glass capillary.
  • Action
    Siemens is advising the customers that they use caution when applying the Capillary Caps with Siemens Multicap glass and Multicap-S plastic capillaries to minimize the potential for breakage or bending. Siemens will be providing new Capillary Caps for the capillary blood collection products by February / March 2015. This action has been closed-out on 20/04/2017.

Device

Siemens Capillary Caps for RAPIDLyte Multicap and Multicap-S Blood Collection Capillaries(An in v...
  • Modèle / numéro de série
    Siemens Capillary Caps for RAPIDLyte Multicap and Multicap-S Blood Collection Capillaries(An in vitro diagnostic medical device (IVD))Siemens Material Numbers: 10311053, 10311054 and 10328655Legacy Part Number: 478601, 478605 and 478527ARTG number: 174701
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

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