Retiro De Equipo (Recall) de Dihydrotestosterone (DHT) RIA

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
  • ID del evento
  • Fecha de inicio del evento
  • País del evento
  • Fuente del evento
  • 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
    The manufacturer noticed that the kmno4 reagent (#3205213) - lot 16h8 - included in the dihydrotestosterone (dht) ria kit may lead to elevated concentrations, especially for male samples. the impact of the affected kmno4 (lot 16h8) was less visible on female samples. because this reagent is used in the extraction step, elevated values were not observed on the standard curve nor on the kit controls. only extracted samples are susceptible to higher results.
  • Acción
    Product to be exchanged


  • Modelo / Serial
    Model: , Affected: Cat. Number. DE5170, Lot. 164808/C
  • Manufacturer