Events

Retiro De Equipo (Recall) de VITROS CHEMISTRY PRODUCTS MIXING CUP ARRAYS

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
    67751
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2013-10-16
  • 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 become aware of an increase in eae condition codes when using vitros 250 or 350 chemistry systems. when customers perform an on-analyzer dilution it is performed by the vitros chemistry system using the vitros mixing cup arrays and diluents. ocd's investigation has found that while performing on-analyzer dilution some customers have reported an increase in eae conditions codes ("sample metering dilution error"). when an eae condition code occurs the processing for that patient sample is automatically cancelled by the system and the user is alerted. ocd's investigation has determined that the increased rate of eae condition codes is attributed to out-of-specification vitros mixing cup arrays. ocd is working with the oem manufacturer of the mixing cup arrays to determine the root cause of the issue.

Device

VITROS CHEMISTRY PRODUCTS MIXING CUP ARRAYS
  • Modelo / Serial
    Model Catalog: 1631779 (Lot serial: > 10 contact manufacturer)
  • Descripción del producto
    VITROS Chemistry Products Mixing Cup Arrays
  • Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS

Manufacturer

ORTHO-CLINICAL DIAGNOSTICS