Events

Retiro De Equipo (Recall) de ORTHO VISION 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
    129627
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2016-02-29
  • 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 (ortho) is issuing this recall due to an unlikely scenario in which a user inappropriately removes or interchanges samples in an onboard sample rack or removes an onboard dilution tray after making a reagents load/unload request. if an unexpected change is made in a load station location that was not selected via the graphical user interface (gui) the system will not detect the change. if users deviate from normal process for changing patient samples the analyzer may not detect the change. in this case samples can be associated with another sample id which can potentially lead to erroneous test results being reported. this issue was identified internally by ortho. to date ortho has received no customer complaints or reports of patient injury due to this issue.

Device

ORTHO VISION ANALYZER
  • Modelo / Serial
    Model Catalog: 6904577 (Lot serial: > 10 serial numbers affected)
  • Descripción del producto
    ORTHO VISION Analyzer
  • Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS

Manufacturer

ORTHO-CLINICAL DIAGNOSTICS