Events

Rappel de Radiometer ABL700 and ABL800 series blood gas analysers. An in vitro diagnostic medical device (IVD). Radiometer pH electrode, 945-614 with pCO2 membrane, 942-063 (D788)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Radiometer Pacific 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-01538-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-12-06
  • 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-2016-RN-01538-1
  • 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
    In july 2013 customers were informed about the possible risk of negative bias on some pco2 results on both blood and qc measurements. as a temporary countermeasure, users were required to manually narrow the qc ranges for pco2 and also perform extra qc measurements when replacing the membrane. the root cause investigation for the pco2 issue revealed a problem with gas leak at the ph electrode. in nov. 2014 a new improved blue sealing ring for the ph electrode was released. radiometer advised that the temporary countermeasure with the qc could be revoked upon installation of the improved sealing ring. further investigation has identified that over time, the dimensions of some of these new blue sealing rings changed. the blue sealing ring was improved and the updated version released in dec. 2015. tests were performed to monitor their performance over time and have shown that the dimensions of the updated sealing rings do not alter. these blue sealing rings are to be installed.
  • Action
    Radiometer will replace the current sealing ring at the Planned Maintenance for the analyser(s) within the next 12 months. If users are experiencing any problems with pCO2 results, they are to contact their Radiometer representative to arrange an earlier time for the replacement of the sealing ring for the pH electrode. When the sealing ring is updated Radiometer will also replace any stock currently held of the 834-682 sealing ring. A Service report will be provided when the sealing ring is replaced.

Device

Radiometer ABL700 and ABL800 series blood gas analysers. An in vitro diagnostic medical device (I...
  • Modèle / numéro de série
    Radiometer ABL700 and ABL800 series blood gas analysers. An in vitro diagnostic medical device (IVD). Radiometer pH electrode, 945-614 with pCO2 membrane, 942-063 (D788)ARTG Number: 229300
  • Manufacturer
    Radiometer Pacific Pty Ltd

Manufacturer

Radiometer Pacific Pty Ltd