Retiro De Equipo (Recall) de Ortho Reagent Red Blood cell Products

Según New Zealand Medicines and Medical Devices Safety Authority, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en New Zealand que fue producido por manufacturer #1479.

¿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
    20924
  • Fecha de inicio del evento
    2016-12-08
  • País del evento
  • Fuente del evento
    NZMMDSA
  • URL de la fuente del evento
  • Notas / Alertas
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Notas adicionales en la data
    Recalling Organisation: Ortho-Clinical Diagnostics, c/o Quigg Partners, Level 7, 36 Brandon Street, Wellington 6011
  • Causa
    Manufacturer has received an increase in customer complaints and has confirmed the intermittent presence of marked hemolysis in ortho reagent red blood cell (rrbc) products as well as quality control products containing red blood cells., an extensive investigation identified microbial contamination as the root cause for the marked hemolysis.
  • Acción
    Manufacturer to issue advice regarding use

Device

  • Modelo / Serial
    Model: 719102, 6902317, 6902315, 6902316, 719402, 719522, 719201, 6902096, 719502, 719810, 6902318, 719210, 6902319, 6901865, 719510, 707910, 7192042, 719602, 719100, 7192041, 6908163, 719610, 707950, 7191041, 719221, 719202, 707930, Affected: Multiple lot numbers
  • Manufacturer

Manufacturer