Events

Alerta De Seguridad para ARCHITECT Anti- HBc II Reagent

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

¿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
    2015-03-02
  • Fecha de publicación del evento
    2015-03-02
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20150302b.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: abbott laboratories architect anti- hbc ii reagent medical device manufacturer, abbott laboratories ltd, has issued a field safety notice concerning architect anti- hbc ii reagent kit, with the following details: list number: 8l44-25; 8l44-30; 8l44-35; lot number: 42072li00; 42072li01; 42253li00; 42253li01; 42255li00; 42255li01; 42256li00 according to the manufacturer, the affected product shows lower calibrator, control and sample relative light unit (rlu) values, potentially leading to reduced specificity and increased false reactive results. internal testing showed specificity dropped to 99.2% which is below the package insert claim of 99.5% on a blood donor population. there is the potential for false reactive patient results but assay sensitivity is not impacted. the manufacturer advises users not to use the affected lots and destroy any remaining inventory of these lots according to their laboratory procedures. according to the local supplier, the affected product is distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 2 march 2015.

Device

ARCHITECT Anti- HBc II Reagent
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Abbott Laboratories ARCHITECT Anti- HBc II Reagent
  • Manufacturer
    Abbott Laboratories Ltd

Manufacturer

Abbott Laboratories Ltd
  • 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