Events

Rappel de IH-Com Kit Full version (Data management and Result Interpretation Software for ABO blood grouping). An in vitro diagnostic medical device (IVD)Used for ABO Blood GroupingAn 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-01215-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2012-11-30
  • 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-01215-1
  • 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 have been reports of results not being interpreted in the anti-ab well (abo3) of id-cards intended for abo forward grouping, the ih-com software doesn't include the reaction of this well when sending the result to the laboratory host (result code-30).This can occur in the following situations;1. ih-com software is connected to the laboratory host through astm communication mode, and2. an "abo not interpretable" result is obtained due to a reaction "?" or "+-" or "dp" in the anti-ab well of the id-card intended for abo forward grouping, and3. the "second reading" option is deactivated and ih-com results are directly sent to the host, or4. the "second reading" option is activated by the the "not interpretable" result is obtained in ih-com directly saved and sent to host without a manual selection by the user in abo scrollbar.
  • Action
    Bio-Rad Laboratories will be providing work around instructions in the customer letter. A software update will be implemented to correct the problem.

Device

IH-Com Kit Full version (Data management and Result Interpretation Software for ABO blood groupin...
  • Modèle / numéro de série
    IH-Com Kit Full version (Data management and Result Interpretation Software for ABO blood grouping). An in vitro diagnostic medical device (IVD)Used for ABO Blood GroupingAn in vitro diagnostic medical device (IVD)
  • Manufacturer
    Bio-Rad Laboratories Pty Ltd

Manufacturer

Bio-Rad Laboratories Pty Ltd