Events

Retiro De Equipo (Recall) de VITROS CHEMISTRY PRODUCTS SYSTEM - 250/250AT ANALYZER

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
    56619
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2013-10-22
  • 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 confirmed that positively biased serum or plasma sample results may occur when using vitros na+ slides gens 7-13. our data determined that the largest bias was observed when using slides from gens 7-13 when calibrated with vitros calibrator kit 2 lots 212 and 292. the amount of bias is dependent upon multiple sources of variability that include but are not limited to the slide gen calibrator kit lot calibration event and vitros system. it is important to note that not all combinations of vitros na+ slide gens and calibrator kit lots resulted in biased na+ results. customers may continue to use their remaining inventory of gens 7-13 providing the following criteria are met: (1) calibration is successful (2) quality control results are within the established range of means/acceptable limits. (3) distribution of normal results for serum or plasma samples are centered within the established reference interval for their laboratory.

Device

VITROS CHEMISTRY PRODUCTS SYSTEM - 250/250AT ANALYZER
  • Modelo / Serial
    Model Catalog: 1662659 (Lot serial: 212); Model Catalog: 1662659 (Lot serial: 292); Model Catalog: 8379034 (Lot serial: GENs 7 - 13)
  • Descripción del producto
    VITROS Chemistry Products Calibrator Kit 2
  • Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS

Manufacturer

ORTHO-CLINICAL DIAGNOSTICS