Events

Rappel de Dade Actin FSL Activated Pro Thromboplastin Time (APTT) Reagent. 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-00170-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2013-02-22
  • 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-00170-1
  • 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
    During recent investigations, siemens healthcare diagnostics has observed that the affected lot numbers show an increase in heparin sensitivity over the shelf life, prolonging activated partial pro thromboplastin times (aptt). this issue is demonstrated by testing with dade® citrol® heparin control, low and high.
  • Action
    Siemens is requesting customers to discontinue the use of the affected lots and discard any remaining inventory of the affected lots. A look back of previously reported Dade Actin FSL APTT results is at the discretion of the laboratory.

Device

Dade Actin FSL Activated Pro Thromboplastin Time (APTT) Reagent. An in vitro diagnostic medical d...
  • Modèle / numéro de série
    Dade Actin FSL Activated Pro Thromboplastin Time (APTT) Reagent. An in vitro diagnostic medical device (IVD).Lot 547311 (Cat. no. B4219-1 / SMN 10445713)Lot 547312 (Cat. no. B4219-2 / SMN 10445714)Lot 547316 (Cat. no. B4219-2J / SMN 10465681)Lot 547316A (Cat. no. B4219-2 / SMN 10445714)Lot 547316AA (Cat. no. B4219-2J / SMN 10465681)ARTG Number: 178501
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

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