Events

Rappel de RAPIDPoint 400/405 Systems Measurement Cartridge (blood gas analysers). 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-2016-RN-01187-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-09-09
  • 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-2016-RN-01187-1
  • 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 has confirmed an error in the value assignment for the chloride calibrators in the rapidpoint 400 and rapidpoint 405 measurement cartridge for certain cartridge serial numbers. the maximum % bias observed due to error ranges from -2.3% at 65mmol/l to +5.9% at 132 mmol/l. at extremely high chloride values (>122 mmol/l), a positive bias of 5% or greater may be observed. there have not been any reports of injury due to this issue. all the other electrolytes (na+, k+, ca++) and blood gas parameters are correctly assigned in these measurement cartridges.
  • Action
    Siemens is advising users to review the chloride calibrators bias information provided in the recall for product correction letter with their Medical Director.

Device

RAPIDPoint 400/405 Systems Measurement Cartridge (blood gas analysers). An in vitro diagnostic me...
  • Modèle / numéro de série
    RAPIDPoint 400/405 Systems Measurement Cartridge (blood gas analysers). An in vitro diagnostic medical device (IVD).RAPIDPoint 400 Measurement Cartridge Siemens Material Numbers (SMN): 10329756, 10341161RAPIDPoint 405 Measurement CartridgeSiemens Material Numbers (SMN): 10844812, 10283222, 10313971, 10310469Cartridge Serial Numbers: 2610900214 through 2621001325ARTG Number: 185171
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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