Events

Rappel de IH-1000 with software version 04.07.02. 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-2018-RN-00245-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2018-03-21
  • 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-00245-1
  • 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
    It has been identified that when a reagent vial with an unreadable barcode is loaded on a reagents rack on ih-1000 (software version 04.07.02) and a test is performed, despite the fact the first reagent is correctly pipetted, the instrument will pipette from the vial with unreadable barcode for all the remaining wells. the system will add serum and continue as normal without alarm.This error happens following a specific sequence of events:1. use ih-1000 in version 04.07.022. load a reagent in a reagent rack3. the barcode on the reagent vial is not readable4. perform a test requiring the reagent with the unreadable barcode 5. validate the results through ih-com.
  • Action
    BioRad is advising customers to restore the previous version of software 04.04.08. Users may contact Bio-Rad Laboratories to arrange for replacement software. BioRad is advising users to review previous results obtained since the installation of the affected software version. This can be done by checking the lot numbers in the daily journal in IH-Com. If the lot number does not appear do not use the test results and perform the test again.

Device

IH-1000 with software version 04.07.02. An in vitro diagnostic medical device (IVD)
  • Modèle / numéro de série
    IH-1000 with software version 04.07.02. An in vitro diagnostic medical device (IVD)Catalogue Number: 001000ARTG Number: 184446(Bio-Rad Laboratories - Instrument/analyser IVDs)
  • Manufacturer
    Bio-Rad Laboratories Pty Ltd

Manufacturer

Bio-Rad Laboratories Pty Ltd