Events

Retiro De Equipo (Recall) de VITROS ECI IMMUNODIAGNOSTIC SYSTEM - CA125II REAGENT PACK - CALIBRATOR

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
    123147
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2013-10-08
  • 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
    Ortho clinical diagnostics (ocd) has received customer complaints regarding a positive shift in patient results when using vitros immunodiagnostic products ca 125 ii reagent packs lots 1260 and above when compared to lot 1240. customers are being informed regarding a shift in results that may be observed when performing patient sample correlation tests between vitros ca 125 ii calibrators and reagent packs lots 1220 1230 1240 and/or 1250 compared to lots 1260 and above. internal testing has determined that the signal for all levels of affected lots of vitros ca 125 ii calibrator increased over the shelf life of the product resulting in negatively biased patient and quality control results. testing has confirmed that this issue is isolated only to lots 1220 1230 1240 and 1250.

Device

VITROS ECI IMMUNODIAGNOSTIC SYSTEM - CA125II REAGENT PACK - CALIBRATOR
  • Modelo / Serial
    Model Catalog: 6800034 (Lot serial: 1250); Model Catalog: 6800034 (Lot serial: 1220); Model Catalog: 6800034 (Lot serial: 1230); Model Catalog: 6800034 (Lot serial: 1240)
  • Descripción del producto
    VITROS Immunodiagnostic Products CA 125 II Calibrator
  • Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS

Manufacturer

ORTHO-CLINICAL DIAGNOSTICS