Events

Alerta De Seguridad para Alere Triage Cardio 3

Según Department of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Hong Kong que fue producido por Alere.

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • Fecha
    2014-02-20
  • Fecha de publicación del evento
    2014-02-20
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20140220a.html
  • Notas / Alertas
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Notas adicionales en la data
    Medical Device Safety Alert
  • Causa
    Medical device safety alert: alere triage cardio 3 medical device manufacturer, alere, has issued a medical device safety alert concerning triage cardio 3 with catalogue number 97400 and lot number w53658b. according to the manufacturer, the affected product was investigated in response to date observed as part of the manufacturer’s routine product performance monitoring program. this lot shows lower than expected result for bnp, ckmb and troponin i which in turn could result in an increased rate of false negative results. testing of external controls would enable the lab to detect if this lot was giving lower than expected results at the time of testing. the manufacturer advises users of the followings: if users have questions about previously reported results, they should consult with resident clinical expert or physician in the setting where the test was performed. users should discontinue use of and discard the affected products. product replacement will be arranged by the manufacturer. according to the manufacturer, the affected products were distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 20 february 2014.

Device

Alere Triage Cardio 3
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Alere Triage Cardio 3
  • Manufacturer
    Alere

Manufacturer

Alere
  • 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
    DH