Events

Rappel de ORTHO PROVUE

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
    93022
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2016-07-11
  • 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) has initiated this recall to customers with an ortho provue analyzer on which the reader camera brightness value (brillo) was detected to be outside of the specified range. the approved specification for the ortho provue? reader camera brightness is 101 to 128. exceeding the upper range limit of 128 could potentially affect the classification of very low strength (<1+) reactions and may grade the reactions negative instead of as indeterminate ("?"). however the risk is reduced by the fact that any processed cards are read at the same camera brightness (brillo) setting that was established at the time that the reference image was created after optics alignment and adjustment procedures were performed.

Device

ORTHO PROVUE
  • Modèle / numéro de série
    Model Catalog: MTS213784 (Lot serial: 057-171-1749)
  • Description du dispositif
    ORTHO ProVue Analyzer
  • Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS

Manufacturer

ORTHO-CLINICAL DIAGNOSTICS