Events

Rappel de CELLSEARCH CIRCULATING TUMOR CELL KIT

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
    36844
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2015-05-19
  • 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
    Janssen diagnostics llc has received reports from customers about the intermittent occurrence of small bead-like structures or "artifacts" appearing in the image gallery for both control cells and patient samples of some cellsearch circulating tumor cell kits. the appearance of individual artifacts is not unusual. however review of the data has demonstrated an increase of artifacts appearing in the image gallery as unassigned events. artifacts are distinguishable from circulating tumor cells (ctcs) as they do not meet the criteria of a ctc. therefore they are not likely to be counted as ctcs when reviewing in the image gallery. however when testing patient samples there is a low probability that this type of artifact could potentially obscure the presence of ctcs.

Device

CELLSEARCH CIRCULATING TUMOR CELL KIT
  • Modèle / numéro de série
    Model Catalog: 7900001 (Lot serial: 0094B); Model Catalog: 7900001 (Lot serial: 0074B)
  • Description du dispositif
    CELLSEARCH CIRCULATING TUMOR CELL KIT
  • Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS

Manufacturer

ORTHO-CLINICAL DIAGNOSTICS