Events

Rappel de VITROS ECI IMMUNODIAGNOSTIC SYSTEM - CA125II REAGENT PACK - CALIBRATOR

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
    123147
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2013-10-08
  • 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 received customer complaints regarding a positive shift in patient results when using vitros immunodiagnostic products ca 125 ii reagent packs lots 1260 and above when compared to lot 1240. customers are being informed regarding a shift in results that may be observed when performing patient sample correlation tests between vitros ca 125 ii calibrators and reagent packs lots 1220 1230 1240 and/or 1250 compared to lots 1260 and above. internal testing has determined that the signal for all levels of affected lots of vitros ca 125 ii calibrator increased over the shelf life of the product resulting in negatively biased patient and quality control results. testing has confirmed that this issue is isolated only to lots 1220 1230 1240 and 1250.

Device

VITROS ECI IMMUNODIAGNOSTIC SYSTEM - CA125II REAGENT PACK - CALIBRATOR
  • Modèle / numéro de série
    Model Catalog: 6800034 (Lot serial: 1250); Model Catalog: 6800034 (Lot serial: 1220); Model Catalog: 6800034 (Lot serial: 1230); Model Catalog: 6800034 (Lot serial: 1240)
  • Description du dispositif
    VITROS Immunodiagnostic Products CA 125 II Calibrator
  • Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS

Manufacturer

ORTHO-CLINICAL DIAGNOSTICS