Events

Rappel de VITROS Mixing Cup Arrays on VITROS 250 Chemistry Systems & VITROS 350 Chemistry Systems. 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.

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-2013-RN-01270-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2013-12-02
  • 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-2013-RN-01270-1
  • 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
    While performing an on-analyser dilution, some customers have reported an increase in eae condition codes (sample metering dilution error). the data indicates that the rate of occurrence for eae codes can vary between 2 and 25% for cups within the affected arrays. when an eae condition code occurs, the processing for that sample is automatically cancelled by the system.Ortho-clinical diagnostic's investigation into the increased rate of eae condition codes determined that some of vitros mixing cup arrays may be out of specification.
  • Action
    Ortho-Clinical Diagnostics is advising their customers to continue using the Mixing Cup arrays as there is currently no alternative available. It is recommended that laboratories perform manual dilutions for samples with low volume rather than using an onboard dilution. This action has been closed-out on 10/02/2016.

Device

VITROS Mixing Cup Arrays on VITROS 250 Chemistry Systems & VITROS 350 Chemistry Systems. An in vi...
  • Modèle / numéro de série
    VITROS Mixing Cup Arrays on VITROS 250 Chemistry Systems & VITROS 350 Chemistry Systems. An in vitro diagnostic medical device (IVD).Product Code: 1631779ARTG Number for VITROS Chemistry Systems:180199
  • Manufacturer
    Ortho-Clinical Diagnostics

Manufacturer

Ortho-Clinical Diagnostics