Events

Rappel de HemosIL PT-Fibrinogen HS PLUS, 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 Werfen Australia 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-2014-RN-01292-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2014-12-12
  • 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-01292-1
  • 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
    Vials manufactured prior to june 2014 from the provided batch numbers may exhibit a yellow / brownish colour after reconstitution (yellow colour or darker) instead of the typical white to off-white colour. vials exhibiting this yellow / brownish colour were observed to cause prolonged clotting times, with several reports of controls being outside of the established ranges. if an affected vial is used with a patient sample, a significant shift in inr greater than 10% could occur with the potential to alter subsequent medical treatment.
  • Action
    Werfen is advising their customers not to use any vials identified as part of this recall, discard all boxes of potentially affected lot numbers of product. It is recommended that previously reported test results are reviewed under the supervision of the Medical Director. This acion has been closed-out on 26/08/2016.

Device

HemosIL PT-Fibrinogen HS PLUS, An in-vitro diagnostic medical device (IVD)
  • Modèle / numéro de série
    HemosIL PT-Fibrinogen HS PLUS, An in-vitro diagnostic medical device (IVD)Part Number: 0008469810Affected Lot Numbers: N1222324, N0333626, N0735317 and N0148094.
  • Classification du dispositif
    Hematology and Pathology Devices
  • Manufacturer
    Werfen Australia Pty Ltd

Manufacturer

Werfen Australia Pty Ltd