Events

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 Diabetes Care.

¿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
    2013-11-28
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20131128b.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
    Further recall of freestyle and freestyle lite blood glucose test strips the department of health (dh) today (november 28) drew public attention to abbott diabetes care's further recall of other lots of its freestyle and freestyle lite blood glucose test strips due to the potential for giving erroneously low blood glucose results. further to the press releases issued by the dh on november 25 and 26 on the recall of certain lots of freestyle and freestyle lite blood glucose test strips by abbott diabetes care, the local supplier abbott laboratories limited informed the dh that 18 other lots of freesytle and freestyle lite blood glucose test strips have to be recalled (lot numbers: 1280623, 1281310, 1281424, 1282651, 1284924, 1355751, 1358061, 1359207, 1365062, 1366208, 1366620, 1369334, 1372550, 1372652, 1373413, 1376121, 1376216 and 1376259). the full list of affected lots is in the appendix. although these affected strips may give rise to erroneous results when used with certain brands and models of glucose meters, the dh advised the public to stop using the affected test strips, irrespective of the brand or model of the glucose meters they are using, as a precautionary measure and to avoid causing confusion. 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. "enquiries with the local supplier, abbott laboratories limited, revealed no evidence of the affected test strips having been distributed in hong kong," the spokesman said. so far, the dh has not received any local reports of adverse events arising from use of the affected products. "people who have test strips belonging to the affected lots listed in the appendix should contact abbott laboratories limited for advice and follow-up," the spokesman stressed. the company has set up a customer service hotline, 5808 4196, to answer related enquiries. ends.

Device

FreeStyle and FreeStyle Lite blood glucose test strips
  • Modelo / Serial
  • Descripción del producto
    Press release: Further recall of FreeStyle and FreeStyle Lite blood glucose test strip
  • Manufacturer
    Abbott Diabetes Care

Manufacturer

Abbott Diabetes Care
  • 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