Events

Rappel de Berichrom Heparin (used in the quantitative and/or qualitative determination of tests associated with the coagulation cascade) (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-00904-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2013-08-26
  • 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-00904-1
  • 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 lots have shown reduced on board stability while used on bcs/bcs xp system or sysmex ca-7000 system as demonstrated by testing appropriate controls e.G. berichrom heparin control 1. the complaints received indicate that there is the potential for invalid runs. although unlikely, it is possible that an erroneously low heparin value may be reported which may trigger a higher dose of heparin therapy which could increase the risk of bleeding.
  • Action
    Siemens Healthcare is advising users to discard any remaining inventory of these lots. Affected lots will be replaced by Siemens Healthcare with unaffected stock. Siemens is not recommending lookback of previously reported Berichrom Heparin results since coagulation status changes over time.

Device

Berichrom Heparin (used in the quantitative and/or qualitative determination of tests associated ...
  • Modèle / numéro de série
    Berichrom Heparin (used in the quantitative and/or qualitative determination of tests associated with the coagulation cascade) (An in vitro diagnostic medical device (IVD))Catalogue Number: OWLD 11Siemens Material Number: 10446620Lot Numbers: 42007, 42082, 42483 and 42569ARTG Number: 178506
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

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