Events

Rappel de VITROS Chemistry Products Na+ Slides. 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 Ortho-Clinical Diagnostics 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-2017-RN-00004-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2017-01-04
  • 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-00004-1
  • 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 issue has been identified where there is a potential for biased results to be generated over the 10 day on-analyzer limit when using vitros na+ slide cartridges warmed between 1½ to 8 hours prior to being placed on the analyser. it has been determined that cartridges require a minimum of 8 hours of warm up at room temperature to help ensure the slides have acceptable performance throughout the 10 day on-analyser storage limit. this issue affects all expired, in-date gens, and future product until further notice.
  • Action
    Ortho Clinical Diagnostics is advising customers to store cartridges at room temperature for a minimum of eight (8) hours prior to calibration. Customers who have discarded cartridges will have their account credited or be sent a replacement.

Device

VITROS Chemistry Products Na+ Slides. An in vitro diagnostic medical device (IVD)

Manufacturer

Ortho-Clinical Diagnostics Australia Pty Ltd