Events

Rappel de Haemoglobin A1c (HbA1c) Flex Reagent Cartridge (An in vitro diagnostic medical device (IVD) used with Dimension Vista Systems)

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-00922-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2014-08-21
  • 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-00922-1
  • 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 confirmed that when whole blood samples are run from small sample container (ssc – ks860 smn 10472099)), hba1c values may exhibit a percent bias ranging from -8.2% to +6.5% compared to results from the primary container. the percent bias range is a percentage of the hba1c result; it is not % hba1c units.
  • Action
    Siemens Healthcare Diagnostics is advising customer not to use Small Sample Containers (SSC) when running whole blood samples with Dimension Vista HbA1c assay and to process HbA1c samples according to the Instructions For Use for Primary Tubes or Sample Cups i.e. samples should be mixed by inversion (gently invert the tube ten times) or in a rocker mixer to obtain uniform distribution of erythrocytes prior to testing. Users are also advised that the need for a look back at previously reported results should be discussed with the laboratories Medical Director.

Device

Haemoglobin A1c (HbA1c) Flex Reagent Cartridge (An in vitro diagnostic medical device (IVD) used ...
  • Modèle / numéro de série
    Haemoglobin A1c (HbA1c) Flex Reagent Cartridge (An in vitro diagnostic medical device (IVD) used with Dimension Vista Systems)Siemens Material Number (SMN): 10470481Catalogue Number: K3105AAll in-date lot numbers are affected ARTG Number: 181689
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

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