Events

Rappel de Radiometer ABL800 FLEX series blood gas analysers with Crea module. 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 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-2018-RN-00900-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2018-07-06
  • 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-00900-1
  • 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
    Radiometer has recently become aware that the abl800 series analysers that measure ccrea may potentially report lower than expected ccrea results on patient samples. the difference has been reported to be as high as -28%.Currently, this problem may not identified by running the qc, as the qc will be lower, but still within range.The underestimated creatinine occurs specifically when measurements on autocheck 6+ level 1 (also known as s7835 autocheck module and abbreviated ac6+l1) are = 230 µm of a specified insert interval for ac6+l1 with insert limits 210–290 µm. ultimately, a lower read-out on patient samples on abl8x7 is observed.This issue may lead to erroneous measurement values for ccrea, and may lead to no detection of renal insufficiency or underestimation of moderate to severe renal failure.
  • Action
    Radiometer requests that users do not report cCrea results until they have verified the performance of the membrane units as described in the Customer Letter. Radiometer is advising that they are improving the cCrea membranes and will advise users accordingly when interim measures are no longer required.

Device

Radiometer ABL800 FLEX series blood gas analysers with Crea module. An in vitro diagnostic medica...
  • Modèle / numéro de série
    Radiometer ABL800 FLEX series blood gas analysers with Crea module. An in vitro diagnostic medical device (IVD)ARTG Number: 228382(Radiometer Pacific Pty Ltd - Instrument/analyser IVDs)
  • Manufacturer
    Radiometer Pacific Pty Ltd

Manufacturer

Radiometer Pacific Pty Ltd