Events

Rappel de ADVIA Chemistry Systems - Urea Nitrogen (UN). 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-00303-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2018-04-06
  • 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-00303-1
  • 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 urea nitrogen reagent kit lots 408143 and 418290 for use on advia 1800, 2400 and xpt chemistry systems are failing to perform as intended due to microbial contamination of a bulk reagent during the manufacturing process. this may demonstrate as an increased incidence of calibration failures. results cannot be generated by the system when calibration fails.If calibration passes, there is a potential for falsely elevated patient and quality control results.Internal testing has also shown that for the affected lots, results have the potential to be falsely increased by approximately 10 mg/dl (3.57 mmol/l) across the analytical range. quality controls may not always detect the elevated results.
  • Action
    Siemens is advising customers to discontinue use of and discard affected kit lots. A replacement for discarded units will be provided.

Device

ADVIA Chemistry Systems - Urea Nitrogen (UN). An in vitro diagnostic medical device (IVD)
  • Modèle / numéro de série
    ADVIA Chemistry Systems - Urea Nitrogen (UN). An in vitro diagnostic medical device (IVD) Catalogue Number: 03040257Lot Numbers: 408143, 418290Expiry (both lots): 28/06/2018ARTG Number: 176642Siemens Healthcare - Clinical chemistry substrate IVDs
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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