Alerta De Seguridad para freestyle and freestyle lite blood 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
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • 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
    Recall of certain lots of freestyle and freestyle lite blood glucose test strips the department of health (dh) today (november 25) drew public attention to abbott diabetes care's recall of certain lots of its two brands of blood glucose test strips, namely freestyle and freestyle lite, due to the potential for giving erroneously low blood glucose results when using in conjunction with certain brands of blood glucose meters also manufactured by the company. the dh, through its routine surveillance on medical devices, noticed a recall notice issued by the therapeutic goods administration (tga) of australia involving two lots of freestyle lite blood glucose test strips (lot number: 1366540 and 1366621). according to tga, the two affected lots have the potential to give readings that are incorrectly low when used in conjunction with freestyle papillon mini blood glucose meters. when conducting follow-up to tga's alert, dh noticed that abbott diabetes care in the us has posted a recall notice on its company website, announcing that certain lots of freestyle and freestyle lite blood glucose test strips (lot numbers: 1281732, 1283345, 1283603, 1285007, 1350414, 1363015, 1363109, 1363321, 1365056, 1365920, 1365921, 1365934, 1366006, 1366111, 1366337, 1366347, 1366515, 1367917, 1373262 and 1374907) may also produce falsely low blood glucose results when they are used with freestyle blood glucose meters, freestyle flash blood glucose meters and the freestyle blood glucose meter built into the omnipod system. a spokesman for the dh explained that falsely low blood glucose readings may mislead a diabetic patient into inappropriate management of his or her condition, resulting in hyperglycemia. "although preliminary enquiry with the local supplier, abbott laboratories limited, reveals no evidence of the affected products having been distributed in hong kong, a public alert is justified as there may be patients in the territory who have obtained the devices or test strips from abroad or from internet purchase," the spokesman remarked. "dh will continue to follow up with the supplier to further verify whether other brands and lots are affected and their distribution," the spokesman said. so far, the dh has not received any local report of adverse events arising from use of the affected products. people who have the test strips belonging to the affected lots and are using the specific brands of glucose meters concerned should contact abbott laboratories limited for advice and follow-up," the spokesman urged. the company has set up a customer service hotline 5808 4196 to answer related enquiries. ends.



  • Empresa matriz del fabricante (2017)
  • 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.
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