Events

Retiro De Equipo (Recall) de CELLSEARCH CIRCULATING TUMOR CELL KIT

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por ORTHO-CLINICAL DIAGNOSTICS.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    36844
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2015-05-19
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    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.
  • Notas adicionales en la data
  • Causa
    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
  • Modelo / Serial
    Model Catalog: 7900001 (Lot serial: 0094B); Model Catalog: 7900001 (Lot serial: 0074B)
  • Descripción del producto
    CELLSEARCH CIRCULATING TUMOR CELL KIT
  • Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS

Manufacturer

ORTHO-CLINICAL DIAGNOSTICS