Events

Retiro De Equipo (Recall) de VITROS CHEMISTRY PRODUCTS 51 FS CHEMISTRY SYS. - REFURBISHED ANAL. CLASS 2

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
    74006
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2013-06-05
  • 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 issued a recall pertaining to a potential malfunction in a wire connector used in the vitros 4600 vitros 5600 and vitros 51 fs systems that were shipped during a specific date range. to date six customers reported the smell of melting plastic or observed smoke originating from their vitros 4600 and 5600 systems. although reports are confined to the vitros 4600 and 5600 systems the same wire connector is also used on vitros 51 fs systems. as a precaution ocd is contacting customers to notify them of this potential malfunction for vitros systems that were shipped during a specific date range.

Device

VITROS CHEMISTRY PRODUCTS 51 FS CHEMISTRY SYS. - REFURBISHED ANAL. CLASS 2
  • Modelo / Serial
    Model Catalog: 6801890 (Lot serial: 34001610); Model Catalog: 6801890 (Lot serial: 34001589); Model Catalog: 680 2445 (Lot serial: 46000159); Model Catalog: 680 2445 (Lot serial: 46000140); Model Catalog: 680 2445 (Lot serial: 46000160); Model Catalog: 680 2445 (Lot serial: 46000142); Model Catalog: 680 2445 (Lot serial: 46000115); Model Catalog: 6802413 (Lot serial: 56001220); Model Catalog: 6802413 (Lot serial: 56001229); Model Catalog: 6802413 (Lot serial: 56001205); Model Catalog: 6802413 (Lot serial: 56001234); Model Catalog: 6802413 (Lot serial: 56001231); Model Catalog: 6802413 (Lot serial: 56001222); Model Catalog: 680 2413 (Lot serial: 56001220); Model Catalog: 680 2413 (Lot serial: 56001229); Model Catalog: 680 2413 (Lot serial: 56001205); Model Catalog: 680 2413 (Lot serial: 56001234); Model Catalog: 680 2413 (Lot serial: 56001231); Model Catalog: 680 2413 (Lot serial: 56001222)
  • Descripción del producto
    VITROS 51 Chemistry System
  • Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS

Manufacturer

ORTHO-CLINICAL DIAGNOSTICS