Events

Rappel de Pipet Tips used with AutoDG System. An in vitro diagnostic medical device

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-2017-RN-01481-1
  • Classe de risque de l'événement
    Class III
  • Date de mise en oeuvre de l'événement
    2017-12-08
  • 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-2017-RN-01481-1
  • 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
    This failure appears as low total volume in the well of the autodg droplet plate after automated droplet generation, and results in low droplet counts when analyzing data in quantasoft. the failure is most frequently observed in columns 2 and 8 of the droplet plate, which corresponds to the fourth column of pipet tips in each box (when loaded with the box label facing front). this issue may impact pipet tip lots listed in the product details table above shipped in 2017and is most frequently observed with pipet tips from column 4 of the pipet tip box. this defect has no safety or efficacy impact, and will not result in erroneous results.
  • Action
    Bio-Rad has decided to continue to ship pipet tips with a short-term workaround detailed in the Customer Letter.

Device

Pipet Tips used with AutoDG System. An in vitro diagnostic medical device
  • Modèle / numéro de série
    Pipet Tips used with AutoDG System. An in vitro diagnostic medical deviceProduct Number: 1864120, 1864121, 12003010Lot Numbers: PR136933, PR137957, PR138863, PR139939, PR136556, PR136109, PR134751, PR135656, PR135220ARTG Number: 296086
  • Manufacturer
    Bio-Rad Laboratories Pty Ltd

Manufacturer

Bio-Rad Laboratories Pty Ltd