Events

Alerta De Seguridad para i-STAT PT/INR Cartridge

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

¿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
    2013-11-04
  • Fecha de publicación del evento
    2013-11-04
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20131104b.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 i-stat pt/inr cartridge the therapeutic goods administration (tga), australia issued a medical device safety alert concerning i-stat pt/inr cartridge, manufactured by abbott point of care division. the affected list number is 3p89-24, and the affected lot numbers are 1 c103139 to and including c13270a. abbott point of care has determined that the i-stat pt/inr cartridge lots have the potential to exhibit incorrectly elevated results. internal studies have demonstrated that i-stat pt/inr results are elevated by an average of approximately 10% as compared to the international reference preparation (rtf/09) in the therapeutic range of 1.8 to 3.0 inr. the manufacture advises users to destroy unused stock. any remaining stock will be replaced by abbott. also, the manufacturer advises that a review of previous results may be performed at the discretion of the laboratory manager. for details, please refer to tga website: http://www.Tga.Gov.Au/sara/arn-detail.Aspx?k=rc-2013-rn-01119-1 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 4 november 2013.

Device

i-STAT PT/INR Cartridge
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Abbott i-STAT PT/INR Cartridge
  • Manufacturer
    Abbott Point of Care Division

Manufacturer

Abbott Point of Care 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
    DH