Retiro De Equipo (Recall) de Abbott RealTime High Risk HPV and RealTime High Risk (HR) HPV Application CD-ROM (for m2000 System)

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 Abbott Molecular Inc.

¿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
    15700
  • Fecha de inicio del evento
    2013-11-21
  • 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: Abbott Diagnostics Division, Ground Floor, Building D, 4 Pacific Rise, Mt Wellington, AUCKLAND 1640
  • Causa
    M2000rt instrument noise is defined as an unexpected cycle-to-cycle variability in the flurorescence signals during the amplification and detection process. abbott molecular has identified that the instrument noise lower limit validy parameter for the realtime hr hpv assay is set outside of the optinal setting to flag excess variability in fluroescence signal. therefore, in the presence of excess noise, incorrect results could be generated.
  • Acción
    Software to be upgraded

Device

  • Modelo / Serial
    Model: List Numbers: 02N09 & 4N05-01, Affected: Version 1.0
  • Manufacturer

Manufacturer

  • Empresa matriz del fabricante (2017)
  • Comentario del fabricante
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    NZMMDSA