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 the united states food and drug administration (fda) has issued a medical device safety alert concerning leadcare testing systems, manufactured by magellan diagnostics. the fda is warning facilities such as laboratories or health clinics that magellan diagnostics’ leadcare testing systems may underestimate blood lead levels (blls) and give inaccurate results when processing venous blood samples. the fda is providing recommendations to help mitigate the risk of inaccurate test results to assure that patients receive accurate information regarding potential lead exposure. the fda is also strongly urging parents and at-risk adults to speak with their health care provider about the u.S. centers for disease control’s (cdc) recommendations on re-testing. the cdc recommends that parents of children younger than six years (72 months) of age, and currently pregnant women and nursing mothers who have been tested for lead exposure consult a health care professional about whether they should be retested. 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. report any adverse events to the fda and to magellan diagnostics. if laboratories or health care professionals 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. this safety communication replaces all previous communication from magellan diagnostics on their leadcare lead testing systems including magellan’s most recent field safety correction notification dated april 28, 2017. for details, please refer to the fda websites: https://www.Fda.Gov/safety/medwatch/safetyinformation/safetyalertsforhumanmedicalproducts/ucm558988.Htm https://www.Fda.Gov/medicaldevices/safety/alertsandnotices/ucm558733.Htm https://www.Fda.Gov/newsevents/newsroom/pressannouncements/ucm558769.Htm if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 18 may 2017.


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