Events

Alerta De Seguridad para I-stat 1 Analyzer system - G3+ 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 Inc.

¿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
    2014-03-21
  • Fecha de publicación del evento
    2014-03-21
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20140321.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 1 analyzer system - g3+ cartridge health canada has issued a medical device safety alert concerning i-stat 1 analyzer system - g3+ cartridge, manufactured by abbott point of care inc. the affected model number is 03p78-25, and the affected lot number is n13183. the manufacturer has determined that i-stat g3+ cartridges from cartridge lot number n13183 have the potential to exhibit incorrectly elevated partial pressure of carbon dioxide (pco2) and depressed ph results. the pco2 results can be elevated by 10 to 25 mmhg while the ph results can be depressed by 0.10 to 0.15. all other g3+ cartridge lots are unaffected by this issue. for details, please visit the following health canada website: http://www.Healthycanadians.Gc.Ca/recall-alert-rappel-avis/hc-sc/2014/38453r-eng.Php if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 21 march 2014.

Device

I-stat 1 Analyzer system - G3+ Cartridge
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Abbott I-stat 1 Analyzer system - G3+ Cartridge
  • Manufacturer
    Abbott Point of Care Inc

Manufacturer

Abbott Point of Care Inc
  • 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