Retiro De Equipo (Recall) de Calprotectin Card (20 test kit with stool vials & positive control)

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 Abacus 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
    21471
  • Fecha de inicio del evento
    2017-05-30
  • 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: Abacus ALS Limited, 55b Richard Pearse Drive, Airport Oaks, Auckland 2022
  • Causa
    Lots cp-052 and cp-047 were evaluated using a strip reader and standard preparations of calprotectin ranging from 125 ng/ml to 4000 ng/ml. comparative results using the strip reader and visual examination showed the intensity of the reactions were stronger on lot cp-047 than lot cp-052. when the concentration of calprotectin in a stool sample is near to the test detection limit (500 ng/ml), some samples could be interpreted as negative, depending on the lot and the visual interpretation.
  • Acción
    Product to be destroyed

Device

Manufacturer