Events

Rappel de ORTHO VISION ANALYZER

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
    129627
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2016-02-29
  • 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 (ortho) is issuing this recall due to an unlikely scenario in which a user inappropriately removes or interchanges samples in an onboard sample rack or removes an onboard dilution tray after making a reagents load/unload request. if an unexpected change is made in a load station location that was not selected via the graphical user interface (gui) the system will not detect the change. if users deviate from normal process for changing patient samples the analyzer may not detect the change. in this case samples can be associated with another sample id which can potentially lead to erroneous test results being reported. this issue was identified internally by ortho. to date ortho has received no customer complaints or reports of patient injury due to this issue.

Device

ORTHO VISION ANALYZER
  • Modèle / numéro de série
    Model Catalog: 6904577 (Lot serial: > 10 serial numbers affected)
  • Description du dispositif
    ORTHO VISION Analyzer
  • Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS

Manufacturer

ORTHO-CLINICAL DIAGNOSTICS