Events

Rappel de VIDAS and mini VIDAS systemsIn vitro diagnostic medical devicesIn combination with Quality Control VIDAS (QCV)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Biomerieux 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-00060-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2018-02-13
  • 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-00060-1
  • 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
    A review of relevant data and feedback from users has identified there are some pump clogging and displacement of the colour coded label. the pump clogging could contribute to erroneous results for any assay performed on the vidas and mini vidas system due to decrease of pipetted volume.
  • Action
    bioMérieux is advising users to implement the following permanent changes in managing the affected systems: 1. Increase the frequency of the QCV testing to weekly rather than monthly to reduce the period of potential retrospective analyses needed. In the event of QCV test fail, it is recommended to review previous results with the laboratory medical director, and perform a retrospective analysis of all patient specimens processed since the last successful QCV test. bioMérieux will update the User Manual to reflect this requirement 2. As indicated within the Instructions For Use, continue to conduct a visual inspection of the SPR after each run (including patient sample test and QCV test) to ensure that the dot on the SPR is still in place In response, bioMérieux is taking action to help ensure the instruments perform as intended: 1. Pumps have to be changed every 7 years 2. bioMérieux will systematically clean the VIDAS/mini VIDAS pumps during the yearly Preventive Maintenance

Device

VIDAS and mini VIDAS systemsIn vitro diagnostic medical devicesIn combination with Quality Contro...
  • Modèle / numéro de série
    VIDAS and mini VIDAS systemsIn vitro diagnostic medical devicesIn combination with Quality Control VIDAS (QCV) (ARTG: 203664)Multiple Affected Reference NumbersARTG Number: 199422 Biomerieux Australia Pty Ltd - Instrument/analyser IVDs
  • Manufacturer
    Biomerieux Australia Pty Ltd

Manufacturer

Biomerieux Australia Pty Ltd