Events

Retiro De Equipo (Recall) de VITROS 3600 IMMUNODIAGNOSTIC SYSTEM - INSTRUMENT

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
    61686
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2014-07-07
  • 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
    Ocd has identified an anomaly with vitros system software version 3.0 & below on the vitros 3600 immunodiagnostic system vitros 4600 chemistry system and vitros 5600 integrated system. internal testing confirmed that under very specific conditions incorrect patient demographics were associated with a sample identification (id) number. this issue may occur when condition code py1-075 is generated for a sample id and the operator does not follow the instructions provided below in the condition review in v-docs.

Device

VITROS 3600 IMMUNODIAGNOSTIC SYSTEM - INSTRUMENT
  • Modelo / Serial
    Model Catalog: 680 2783 (Lot serial: 36000627); Model Catalog: 680 2783 (Lot serial: 36000264); Model Catalog: 680 2783 (Lot serial: 36000130); Model Catalog: 680 2413 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 680 2445 (Lot serial: >10 NUMBERS CONTACT MFG)
  • Descripción del producto
    VITROS 3600 IMMUNODIAGNOSTIC SYSTEM (LICENCE #80702)
  • Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS

Manufacturer

ORTHO-CLINICAL DIAGNOSTICS