Events

Rappel de RAPIDPoint 500 Measurement Cartridges. 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-2014-RN-00601-1
  • Classe de risque de l'événement
    Class III
  • Date de mise en oeuvre de l'événement
    2014-06-03
  • 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-2014-RN-00601-1
  • 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 received several reports from customers of one or more electrolyte parameters (e.G., na+, ca++, k+, cl-) reporting a “-----?” error code when aqc, qc, or cvm is run on the rapidpoint 500 blood gas analyzer. when exhibited, the issue is usually seen during level 1 qc /aqc, level 1 cvm, and sometimes level 2 cvm testing. this issue has also been observed on a small number of patient samples.
  • Action
    Customers are advised that the following steps can be taken to mitigate the issue: - Install a RAPIDPoint 500 Measurement Cartridge or - Install a 405 Measurement Cartridge. Customers will need to arrange to get the lactate results from other instruments in their central laboratory since the Lactate parameter is not available on the RAPIDPoint 405 cartridge or - Use an alternative system to obtain the electrolyte values. Since this issue is not related to the AQC cartridge, installing a new AQC cartridge will not solve the problem.

Device

RAPIDPoint 500 Measurement Cartridges. An in vitro diagnostic medical device (IVD)
  • Modèle / numéro de série
    RAPIDPoint 500 Measurement Cartridges. An in vitro diagnostic medical device (IVD)Part numbers: 10844813, 10491447, 10491448 & 10491449Serial Numbers: 2334500011 to 2412705915ARTG number: 176642
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

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