Events

Rappel de IH-1000 Immunohaemotology Analyser. 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-2013-RN-00456-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2013-05-16
  • 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-00456-1
  • 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
    An error relative to the liquid reagents management (test cells or anti-serum vials) might occur if the following conditions are present:1. ih-1000 is in status “ready to start” and:2. the user requests the unloading of a reagent rack while the system is creating the internal batch (the time slot during which the error could occur is about 2 seconds);3. another is loaded immediately afterwards in the same position.If all three conditions are present, the ih-1000 may not use the full set of liquid reagents required to perform the tests of the ongoing batch.Due to a software failure, the system may only use the vial placed in the first position of the re-loaded rack for all the tests of the ongoing batch.
  • Action
    Bio-Rad is providing end users with work around instructions to mitigate the risk of incorrect results. A permanent correction will be made in the next software update.

Device

IH-1000 Immunohaemotology Analyser. An in vitro Diagnostic Medical Device (IVD)
  • Modèle / numéro de série
    IH-1000 Immunohaemotology Analyser. An in vitro Diagnostic Medical Device (IVD)Product REF: 001000All software versionsARTG number: 184446
  • Manufacturer
    Bio-Rad Laboratories Pty Ltd

Manufacturer

Bio-Rad Laboratories Pty Ltd