Events

Rappel de VITROS ECI IMMUNODIAGNOSTIC SYSTEM ANTI-HBS REAGENT/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
    58423
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2013-10-29
  • 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
    Ortho clinical diagnostics (ocd) is notifying customers of the potential for non-reproducible and unexpected positive results for negative anti-hbs reagent packs lots 2280 2290 2302 and 2310. these lots were distributed beginning in november 2012 and all lots have now expired. ocd internal data indicates that the rate of occurrence is variable the maximum observed rate of occurrence for the affected lots was 4 out of 104 negative anti-hbs patient samples which represents approximately 3.9% of negative samples tested. users are being advised to review all previously reported results between >12 and <30 miu/ml. a false positive result considers that a person is presumed to be immune to an hbv infection leaving the person susceptible to an hbv infection.

Device

VITROS ECI IMMUNODIAGNOSTIC SYSTEM ANTI-HBS REAGENT/CALIBRATOR
  • Modèle / numéro de série
    Model Catalog: 1787753 (Lot serial: 2310); Model Catalog: 1524693 (Lot serial: 2310); Model Catalog: 1787753 (Lot serial: 2302); Model Catalog: 1524693 (Lot serial: 2280); Model Catalog: 1787753 (Lot serial: 2290); Model Catalog: 1524693 (Lot serial: 2290); Model Catalog: 1787753 (Lot serial: 2280); Model Catalog: 1524693 (Lot serial: 2302)
  • Description du dispositif
    VITROS Immunodiagnostic Products Anti-HBs Calibrator and Reagent Pack
  • Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS

Manufacturer

ORTHO-CLINICAL DIAGNOSTICS