Events

Rappel de Dimension and Dimension Vista Gentamicin (GENT) Flex reagent cartridge. 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 Healthcare 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-2018-RN-00363-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2018-05-03
  • 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-2018-RN-00363-1
  • 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 dimension gentamicin (gent) may exhibit inaccuracy for quality control (qc) and patient samples at the low end of the analytical measurement range. maximum negative bias of 100% and 48% were observed for patient samples at 0.9 mg/l [1.94 µmol/l] and 1.9 mg/l [4.1 µmol/l], respectively. patient samples at = 2.6 mg/l [5.62 µmol/l] did not show a bias. the bias is due to the calibration curve not showing separation between the level 1 and level 2 calibrators.
  • Action
    Siemens is advising customers to inspect stock, discontinue use of and discard the affected Dimension and Dimension Vista GENT lots.

Device

Dimension and Dimension Vista Gentamicin (GENT) Flex reagent cartridge. An in vitro diagnostic me...
  • Modèle / numéro de série
    Dimension and Dimension Vista Gentamicin (GENT) Flex reagent cartridge. An in vitro diagnostic medical device (IVD).Lot Numbers: EB8115, BB8159, FB8275,17135BC, 17150BF, 17159BD, 17178AC, 17269BD,17312BBSerial Numbers: 10444927, 10445120ARTG Number: 182220
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

Siemens Healthcare Pty Ltd
  • Société-mère du fabricant (2017)
    Siemens AG
  • Source
    DHTGA