Events

Rappel de VITROS CHEMISTRY PRODUCTS 51 CHEMISTRY SYSTEM - REFURBISHED INSTRUMENT

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada 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
    14940
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2015-06-30
  • Pays de l'événement
    Canada
  • Source de l'événement
    HC
  • Notes / Alertes
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Notes supplémentaires dans les données
  • Cause
    Ortho clinical diagnostics (ocd) has identified a software anomaly that may occur during the installation of an assay data diskette (add) using software versions 2.2.1 through 2.8. the anomaly is not caused by the add. ocd received two customer complaints (outside of canada) that occurred during the installation of the add... due to a software coding error for both scenarios all default settings were restored from the add instead of retaining the user configured parameters and the operator was not alerted by the system. if this anomaly occurs the vitros 51 fs system may process samples using the default reporting units from the add instead of the user modified parameters (i.E. si vs conventional units). however numerical results will be correct for the actual units reported on the vitros system.

Device

VITROS CHEMISTRY PRODUCTS 51 CHEMISTRY SYSTEM - REFURBISHED INSTRUMENT
  • Modèle / numéro de série
    Model Catalog: 6801890 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 6801375 (Lot serial: >10 NUMBERS CONTACT MFG)
  • Description du dispositif
    VITROS 51 FS CHEMISTRY SYSTEM (REFURBISHED) (LICENCE #67361)
  • Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS

Manufacturer

ORTHO-CLINICAL DIAGNOSTICS