Events

Rappel de VITROS CHEMISTRY PRODUCTS MIXING CUP ARRAYS

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
    67751
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2013-10-16
  • 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 become aware of an increase in eae condition codes when using vitros 250 or 350 chemistry systems. when customers perform an on-analyzer dilution it is performed by the vitros chemistry system using the vitros mixing cup arrays and diluents. ocd's investigation has found that while performing on-analyzer dilution some customers have reported an increase in eae conditions codes ("sample metering dilution error"). when an eae condition code occurs the processing for that patient sample is automatically cancelled by the system and the user is alerted. ocd's investigation has determined that the increased rate of eae condition codes is attributed to out-of-specification vitros mixing cup arrays. ocd is working with the oem manufacturer of the mixing cup arrays to determine the root cause of the issue.

Device

VITROS CHEMISTRY PRODUCTS MIXING CUP ARRAYS
  • Modèle / numéro de série
    Model Catalog: 1631779 (Lot serial: > 10 contact manufacturer)
  • Description du dispositif
    VITROS Chemistry Products Mixing Cup Arrays
  • Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS

Manufacturer

ORTHO-CLINICAL DIAGNOSTICS