Events

Retiro De Equipo (Recall) de Hemoglobin A1c (HbA1c) ReagentAn in vitro medical device.

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Abbott Australasia Pty Ltd Diagnostic Division.

¿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
    RC-2017-RN-01539-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-12-22
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01539-1
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Notas adicionales en la data
  • Causa
    Abbott has identified fetal hemoglobin (hbf) interference occurs at a level lower than what is stated in the hba1c reagent package insert. the package insert states that the hba1c assay is susceptible to interference effects from hbf at > 20%, while the most current data shows interference from hbf at > 5%. hba1c results are invalid for patients with abnormal amounts of hbf, including those with known hereditary persistence of fetal hemoglobin. in healthy adults, approximately 95% of hb is hba, with small amounts (<3.5%) of hba2 and hbf present.
  • Acción
    Abbott is advising customers to be aware that falsely depressed results could occur when the HbF variant level in patient samples in >5%. Additional updates to the HbA1c reagent package insert will be provided to users once available.

Device

Hemoglobin A1c (HbA1c) ReagentAn in vitro medical device.

Manufacturer

Abbott Australasia Pty Ltd Diagnostic Division
  • Empresa matriz del fabricante (2017)
    Abbott Laboratories
  • 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
    DHTGA