Alerta De Seguridad para LeadCare Testing Systems

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

¿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
  • Fecha de publicación del evento
  • 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
    Medical Device Safety Alert
  • Causa
    Medical device safety alert: magellan diagnostics leadcare testing systems (update) the united states food and drug administration (fda) has issued a statement on findings from ongoing investigation into lead testing issues and an updated medical device safety alert concerning leadcare testing systems, manufactured by magellan diagnostics. the fda has conducted investigations with magellan diagnostics as well as becton dickinson (bd), the manufacturer of blood sample collection tubes used alongside with the lead tests, to determine the cause of the inaccurate lead test results from the leadcare testing systems. the fda concluded that there was a significant chance of false results with magellan’s leadcare tests when used with whole blood collected from the vein and stored in certain bd tubes. upon further investigations, bd determined that the affected tubes’ rubber stoppers contain a chemical called thiuram that can release sulfur-containing gases that dissolve into blood samples and bind tightly to lead particles. this chemical reaction makes it difficult for the magellan lead tests to detect the correct amount of lead in a sample. the fda recommends laboratories and health care professionals take the following actions: discontinue using magellan's leadcare system testing systems with venous blood samples. at this time, all leadcare systems can be used with capillary blood samples. if they are concerned about using the leadcare test systems, the alternative options are mass spectrometry or atomic absorption methods. these are not point-of-care tests, and may be available only from larger-capacity laboratories such as reference labs. for details, please refer to the fda website: https://www.Fda.Gov/newsevents/newsroom/pressannouncements/ucm602343.Htm https://www.Fda.Gov/safety/medwatch/safetyinformation/safetyalertsforhumanmedicalproducts/ucm558988.Htm for information of our previous important safety alert, please refer to mdco website: http://www.Mdco.Gov.Hk/english/safety/recalls/recalls_20170518.Html if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 23 march 2018.


  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Magellan Diagnostics LeadCare Testing Systems (Update)
  • Manufacturer