Events

Rappel de VITROS ECI IMUNODIAGNOSTIC SYSTEM ANTI-HCV REAGENT PACK

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
    50401
  • Classe de risque de l'événement
    III
  • Date de mise en oeuvre de l'événement
    2000-05-29
  • 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
    Have observed a very small number of packs that contained aberrant wells that produced a low signal and may cause a condition code (541-014) or an incorrect result.

Device

VITROS ECI IMUNODIAGNOSTIC SYSTEM ANTI-HCV REAGENT PACK
  • Modèle / numéro de série
    Model Catalog: 6800731 (Lot serial: ALL LOTS BELOW 161); Model Catalog: 1940667 (Lot serial: ALL LOTS BELOW 161); Model Catalog: 1318450 (Lot serial: ALL LOTS BELOW 161); Model Catalog: 1062306 (Lot serial: ALL LOTS BELOW 100); Model Catalog: 1515154 (Lot serial: ALL LOTS BELOW 112); Model Catalog: 1920115 (Lot serial: ALL LOTS BELOW 100); Model Catalog: 192 5551 (Lot serial: ALL LOTS BELOW 112); Model Catalog: 1009406 (Lot serial: ALL LOTS BELOW 112); Model Catalog: 1100387 (Lot serial: ALL LOTS BELOW 71); Model Catalog: 8577413 (Lot serial: ALL LOTS BELOW 71); Model Catalog: 8583130 (Lot serial: ALL LOTS BELOW 90); Model Catalog: 813 6384 (Lot serial: ALL LOTS BELOW 90); Model Catalog: 1009406 (Lot serial: ALL LOTS BELOW 90); Model Catalog: 6800281 (Lot serial: ALL LOTS BELOW 90); Model Catalog: 6800376 (Lot serial: ALL LOTS BELOW 90); Model Catalog: 189 6836 (Lot serial: ALL LOTS BELOW 101); Model Catalog: 6800377 (Lot serial: ALL LOTS BELOW 101); Model Catalog: 8650939 (Lot serial: ALL LOTS BELOW 101); M
  • Description du dispositif
    VITROS IMMUNODIAGNOSTIC PRODUCTS RE PA
  • Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS

Manufacturer

ORTHO-CLINICAL DIAGNOSTICS