Events

Alerta De Seguridad para Optium Omega glucose test strips

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

¿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
    2011-01-11
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/press_20110111.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
    Press release
  • Causa
    Resumption of sale of abbott's optium omega glucose test stripsthe department of health (dh) has today (january 11) agreed to allow one brand of abbott's glucose test strips, optium omega, to re-enter the market. a spokesman for dh said that the decision was based on consideration of information in hand, especially the differences in design and manufacturing of optium omega and the supply of alternatives on the market. dh, through its routine surveillance system, captured a us food and drug administration (fda) alert about the recall of over 380 lots, involving some 10 brands, of glucose test strips marketed by abbott diabetes care in the us late last december.? this is due to ineffectiveness of the strips - there are possibilities of obtaining falsely low blood glucose readings instead.? to allow time for proper investigation and as a precautionary measure to safeguard hong kong's public health, dh requested the local medical device supplier, abbott laboratories limited, to recall all its glucose test strips from consumers on december 29 last year. "as optium omega's unique design and manufacturing could ensure its exemption from ineffectiveness, dh thinks it reasonable to allow its re-entry into the local market, especially alternatives are not in abundance here in hong kong," a dh spokesman explained. "however, any time users are in doubt of the accuracies, they should stop using the strips and consult their healthcare providers," he further remarked. dh would continue to follow-up with the investigation and also closely monitor the recall of other brands of abbott’s glucose test strips. ends/tuesday, january 11, 2010.

Device

Optium Omega glucose test strips
  • Modelo / Serial
  • Descripción del producto
    Press release: Resumption of Sale of Abbott's Optium Omega glucose test strips
  • Manufacturer
    Abbott Laboratories

Manufacturer

Abbott Laboratories
  • 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