Events

Rappel de Dimension Vista Calcium (CA) 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-00106-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2018-02-05
  • 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-00106-1
  • 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 the affected dimension vista calcium (ca) flex reagent cartridge may produce erroneously low results from specific well sets. quality control (qc) may not detect the issue prior to patient testing if the ca calibration and qc are both processed in either an affected or unaffected well set.If ca reagent calibration is performed using an unaffected well set and qc and samples are subsequently processed using an affected well set, ca results may be falsely depressed, with observed biases from -0.075 mmol/l] to -0.7 mmol/l. if a ca reagent calibration is performed using an affected well set, and qc and patient samples are subsequently processed using an unaffected well set, ca results may be falsely elevated. the observed bias for serum, plasma, and urine specimens are similar.
  • Action
    Siemens Healthcare is advising users to discontinue use of, and discard the Dimension Vista Calcium Flex reagent lot 17171BD.

Device

Dimension Vista Calcium (CA) Flex reagent cartridge. An in vitro diagnostic medical device (IVD)
  • Modèle / numéro de série
    Dimension Vista Calcium (CA) Flex reagent cartridge. An in vitro diagnostic medical device (IVD)Catalogue Number: K1023Siemens Material Number: 10445160Lot Number: 17171BDARTG Number:181686
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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