Events

Rappel de IH-1000 (immuno-haematology instrument). 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-2014-RN-01195-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2014-11-10
  • 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-2014-RN-01195-1
  • 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
    Further to a customer complaint, bio-rad have confirmed that in the specific conditions detailed below, the ih-1000 software may lose the link sample/”test in progress”. this loss might lead to a mismatch between the test result and the patient sample.This issue is linked to the sample management when using the “emergency* button” and might occur only in the following conditions:- a not urgent rack (green label) is inserted with more than one sample and;- all the samples on this rack are manually selected as “emergency” by clicking on the “emergency* button”;then once the first emergency sample is processed, the instrument ejects the rack before all processing is completed.- if a rack is then reloaded with new samples in the exact same positions and reinserted in the same slot, the link sample/”test in progress” is lost.
  • Action
    This issue will be permanently corrected in the next IH-1000 software version. This version will be released by the end of Q1 2015. In the meantime, customers should immediately discontinue using the “emergency button” and should process all emergency samples exclusively on the urgent rack.

Device

IH-1000 (immuno-haematology instrument). An in vitro diagnostic medical device (IVD)
  • Modèle / numéro de série
    IH-1000 (immuno-haematology instrument). An in vitro diagnostic medical device (IVD)Catalogue Number: 001000VAffected Version - All SoftwareARTG number: 184446
  • Manufacturer
    Bio-Rad Laboratories Pty Ltd

Manufacturer

Bio-Rad Laboratories Pty Ltd