Events

Rappel de VITROS CHEMISTRY PRODUCTS SYSTEM - 250/250AT 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
    56619
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2013-10-22
  • 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
    Ocd has confirmed that positively biased serum or plasma sample results may occur when using vitros na+ slides gens 7-13. our data determined that the largest bias was observed when using slides from gens 7-13 when calibrated with vitros calibrator kit 2 lots 212 and 292. the amount of bias is dependent upon multiple sources of variability that include but are not limited to the slide gen calibrator kit lot calibration event and vitros system. it is important to note that not all combinations of vitros na+ slide gens and calibrator kit lots resulted in biased na+ results. customers may continue to use their remaining inventory of gens 7-13 providing the following criteria are met: (1) calibration is successful (2) quality control results are within the established range of means/acceptable limits. (3) distribution of normal results for serum or plasma samples are centered within the established reference interval for their laboratory.

Device

VITROS CHEMISTRY PRODUCTS SYSTEM - 250/250AT ANALYZER
  • Modèle / numéro de série
    Model Catalog: 1662659 (Lot serial: 212); Model Catalog: 1662659 (Lot serial: 292); Model Catalog: 8379034 (Lot serial: GENs 7 - 13)
  • Description du dispositif
    VITROS Chemistry Products Calibrator Kit 2
  • Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS

Manufacturer

ORTHO-CLINICAL DIAGNOSTICS