Events

Rappel de IMMAGE IMMUNOCHEMISTRY SYSTEM RF RHEUMATOID FACTOR REAGENT

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par BECKMAN COULTER CANADA L.P..

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
    80715
  • Classe de risque de l'événement
    III
  • Date de mise en oeuvre de l'événement
    2011-06-03
  • 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
    Beckman coulter has confirmed that for lot numbers m908398 and m911529 of immager immunochemistry systems rheumatoid factor reagent known negative results are being reported as slightly positive (between 20 and 30 iu/ml usually). when tested on other methods or with other lots most of these slightly positive samples read < 20 iu/ml or negative. per the cis 95% of normal healthy individuals who live in southern california should have results less than 20 iu/ml. customers utilizing these lots are reporting patient results in more than 5% of their samples with results greater than 20 iu/ml.

Device

IMMAGE IMMUNOCHEMISTRY SYSTEM RF RHEUMATOID FACTOR REAGENT
  • Modèle / numéro de série
    Model Catalog: 447070 (Lot serial: M908398); Model Catalog: 447070 (Lot serial: M911529)
  • Description du dispositif
    IMMAGE IMMUNOCHEMISTRY SYSTEM RF RHEUMATOID FACTOR REAGENT
  • Manufacturer
    BECKMAN COULTER CANADA L.P.

Manufacturer

BECKMAN COULTER CANADA L.P.