Events

Alerta De Seguridad para ARCHITECT Lactic Acid

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

¿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
    2016-10-13
  • Fecha de publicación del evento
    2016-10-13
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20161013a.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 architect lactic acid medical device manufacturer, abbott laboratories limited, has issued a medical device safety alert concerning its architect lactic acid [list number: 9d89-21; lot number (expiration date): 31497un14 (17 oct 2016); 09353un15 (12 feb 2017); 45216un15 (12 may 2017); 14596un15 (30 jul 2017); 37055un15 (12 oct 2017); 14782un16 (21 apr 2018)]. the manufacturer has identified negative interference from the drug n-acetyl cysteine (nac) with the architect lactic acid reagent (ln 9d89-21). according to the manufacturer, the levels of interference observed at nac concentrations of 80 mg/l (0.49 mmol/l) and 800 mg/l (4.9 mmol/l) have been outlined in the field safety notice (fsn). patients undergoing treatment with nac may have falsely depressed lactic acid results. the affected users are advised to take the following actions: review the fsn with their medical director taking the fsn into consideration, they may continue to use architect lactic acid reagent (ln 9d89-21) retain the fsn for their laboratory records according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 13 october 2016.

Device

ARCHITECT Lactic Acid
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Abbott ARCHITECT Lactic Acid
  • Manufacturer
    Abbott Laboratories Limited

Manufacturer

Abbott Laboratories Limited
  • 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