Events

Retiro De Equipo (Recall) de VITROS 5600 INTEGRATED SYSTEM - SOFTWARE

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
    90870
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2012-05-28
  • 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 51 fs system version 2.6.1 software and below and vitros 5600 integrated system software version 2.0 and below. for the ease of workflow vitros analyzers allow multiple lots of the same reagent to be on board the system at the same time. the system automatically switches to the next lot when the "in use" lot is depleted or when the operator manually changes the lot that is in use. in this issue following a successful calibration of the new gens of vitros vanc [vancomycin] reagent (gen 21 and up) or vitros valp [valproic acid] reagent ( gen 16 and up) the system can unexpectedly switch and use the previous (old) lot on board the system to process post-calibration quality control samples. if the operator doesn't notice the lot switch condition code (pv2-097) posted on their screen the new calibration may not be verified by the proper quality control (qc) verification. based on that biased results could potentially occur from a calibration that is suboptimal.

Device

VITROS 5600 INTEGRATED SYSTEM - SOFTWARE
  • Modelo / Serial
    Model Catalog: 680 2864 (Lot serial: > 10 contact manufacturer.); Model Catalog: 6801886 (Lot serial: > 10 contact manufacturer.)
  • Descripción del producto
    VITROS 5600 Integrated System Software Version 2.0 & Below
  • Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS

Manufacturer

ORTHO-CLINICAL DIAGNOSTICS