Events

Retiro De Equipo (Recall) de VITROS CHEMISTRY PRODUCTS 51 FS CHEMISTRY SYST.-RF(RHEUMATOID FACT.) ASSAY

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
    103418
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2011-11-11
  • 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) was notified by its supplier that lot 1630 of calibration kit 16 would not meet its specified 12-month stability. ocd testing indicates that patient results generated using vitros chemistry products rf reagent calibrated with vitros calibrator kit 16 lot 1630 may demonstrate a positive bias across the measuring range of 8.6-120 iu/ml if a new calibration is performed. the positive bias is readily identifiable by routine post-calibration quality control testing with control fluids. to date ocd has not received any complaints related to this issue.

Device

VITROS CHEMISTRY PRODUCTS 51 FS CHEMISTRY SYST.-RF(RHEUMATOID FACT.) ASSAY
  • Modelo / Serial
    Model Catalog: 6801700 (Lot serial: 1630)
  • Descripción del producto
    VITROS Chemistry Calibration Kit 16
  • Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS

Manufacturer

ORTHO-CLINICAL DIAGNOSTICS