Events

Rappel de MAS chemTRAK – H Level 1 Control. 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 Thermo Fisher Scientific 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-2018-RN-00596-1
  • Classe de risque de l'événement
    Class III
  • Date de mise en oeuvre de l'événement
    2018-05-29
  • 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-00596-1
  • 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
    The control's open-vial stability claim for all constituents is "once opened, vials of chemtrak - h are stable for 14 days when stores tightly capped at 2-8deg c". the manufacturer has confirmed that one constituent of the control, glucose, does not meet this stability claim as the recovery of this constituent trends down prior to the stated open-vial usage. the open-vial stability claim of 14 days remains unchanged for the other glucose levels, chu20022a and chu20023a.
  • Action
    Thermo Fisher are advising customers to continue to use Level 1 of the chemTRAK control after the initial thaw for a period of 5 days and discard the control after this period.

Device

MAS chemTRAK – H Level 1 Control. An in vitro diagnostic medical device (IVD).
  • Modèle / numéro de série
    MAS chemTRAK – H Level 1 Control. An in vitro diagnostic medical device (IVD). Catalogue Number: CHU-1Lot Number: CHU20021AARTG Number: 192625(Thermo Fisher Scientific Australia Pty Ltd - Multiple clinical chemistry constituent IVDs)
  • Manufacturer
    Thermo Fisher Scientific Australia Pty Ltd

Manufacturer

Thermo Fisher Scientific Australia Pty Ltd