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
    63028
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2014-11-20
  • 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 identified an anomaly with vitros system software version 3.1 and below. ocd determined that the software may not properly identify an expired calibration. calibration status is monitored by the system software which is based upon the calibration interval and the date of the last calibration. ocd's investigation confirmed that if the anomaly occurs a calibration may expire but the system may not alert the operator and not flag results with a ce sample result code (i.E. calibration expired). the system may unexpectedly generate results even though it is configured to not report results when a calibration has expired.

Device

VITROS 3600 IMMUNODIAGNOSTIC SYSTEM - INSTRUMENT
  • Modelo / Serial
    Model Catalog: 680 2783 (Lot serial: 36000130); Model Catalog: 680 2783 (Lot serial: 36000627); Model Catalog: 680 2783 (Lot serial: 36000264); 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