Events

Rappel de VITROS ECI IMMUNODIAGNOSTIC ANALYZER - CLASS II

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
    80204
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2011-08-29
  • 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
    There is a software issue that may affect results from diluted samples run on the vitros eci immunodiagnostic system tested with the vitros immunodiagnostics products total beta-hcg ii reagent pack. ocd has received complaints of observed results from diluted samples that were reported as <2.39 miu/ml (iu/l) instead of the correct 'no result' which is accompanied by an invalid dilution (id) code. the diluted results were inconsistent with results from the neat (undiluted) sample which was within the measuring range of 2.39-15000 miu/ml.

Device

VITROS ECI IMMUNODIAGNOSTIC ANALYZER - CLASS II
  • Modèle / numéro de série
    Model Catalog: 863 3893 (Lot serial: Lots 0484 and above); Model Catalog: 1922814 (Lot serial: Lots 0484 and above)
  • Description du dispositif
    VITROS ECi/ECiQ Immunodiagnostic Systems Software V 3.8 & below/VITROS Immunodiagnostic Products Total beta-hCG II Reagent Packs Lots 0484 & Above
  • Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS

Manufacturer

ORTHO-CLINICAL DIAGNOSTICS