Events

Rappel de Urinary Catecholamines by HPLC Reagent Kits, Automated Method on Gilson ASPEC. 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 Bio-Rad Laboratories 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-2012-RN-01295-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2012-12-24
  • 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-2012-RN-01295-1
  • 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
    There is a risk of false negative results being reported in urine samples; the concentration of adrenaline/epinephrine may decrease when analysis time is more than 8 hours. this occurs when the samples are subsequently adjusted to ph 5 to 7 as described in the instructions for use for very acidic samples or samples with low 24-volumes.
  • Action
    The sponsor is providing an update to the Instructions for Use (IFU).

Device

Urinary Catecholamines by HPLC Reagent Kits, Automated Method on Gilson ASPEC. An in vitro diagno...
  • Modèle / numéro de série
    Urinary Catecholamines by HPLC Reagent Kits, Automated Method on Gilson ASPEC. An in vitro diagnostic medical device (IVD)Catalogue Number: 1955700
  • Manufacturer
    Bio-Rad Laboratories Pty Ltd

Manufacturer

Bio-Rad Laboratories Pty Ltd