Events

Rappel de SYNCHRON Systems Lactate (LACT), 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 Beckman Coulter Australia 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-2013-RN-00364-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2013-04-22
  • 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-2013-RN-00364-1
  • 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
    Beckman coulter has received customer reports of suppressed lact results for samples containing lact concentration of 6.5 mmol/l or greater, when using the affected lot number. internal testing confirmed that the issue for samples containing lact concentrations between 9.2 and 11.0 mmol/l. although these results are within the analytical range of 0.3 - 11.0 mmol/l, the results are suppressed and the system identifies the error condition rxn rate hl.
  • Action
    Beckman Coulter is asking users to cease using the affected lot and is offering a replacement.

Device

SYNCHRON Systems Lactate (LACT), An in vitro diagnostic medical device (IVD)
  • Modèle / numéro de série
    SYNCHRON Systems Lactate (LACT), An in vitro diagnostic medical device (IVD)Reference: A95550Lot Number: M206209Expiry: 2013-04-30
  • Manufacturer
    Beckman Coulter Australia Pty Ltd

Manufacturer

Beckman Coulter Australia Pty Ltd