Events

Rappel de VITROS 3600 Immunodiagnostic Systems, VITROS 4600 Chemistry Systems & VITROS 5600 Integrated Systems (Software Versions 3.0 & below)

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-2014-RN-00765-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2014-07-09
  • 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-2014-RN-00765-1
  • 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
    Internal investigation confirmed that under specific circumstances, patient demographics may be incorrectly associated with a sample id number. this issue may occur when condition code py1-075 is generated for a sample id and the operator does not follow the instructions provided below in the condition review in v-docs.
  • Action
    End users are advised to move the sample to different cup and position if a PY1-075 condition code occurs on your VITROS® 3600, 4600 or 5600 System during sample processing. A correction will be included in the next scheduled software update. This action has been closed-out on 06/07/2016.

Device

VITROS 3600 Immunodiagnostic Systems, VITROS 4600 Chemistry Systems & VITROS 5600 Integrated Syst...
  • Modèle / numéro de série
    VITROS 3600 Immunodiagnostic Systems, VITROS 4600 Chemistry Systems & VITROS 5600 Integrated Systems (Software Versions 3.0 & below) VITROS 3600 Immunodiagnostic System System Product Code: 6802783 VITROS 4600 Chemistry System System Product Code: 6802445 VITROS 5600 Integrated System System Product Code: 6802413
  • Manufacturer
    Ortho-Clinical Diagnostics

Manufacturer

Ortho-Clinical Diagnostics