Events

Alerta De Seguridad para NADAL hCG Pregnancy rapid test

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

¿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
    2017-01-04
  • Fecha de publicación del evento
    2017-01-04
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20170104.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: nal von minden nadal hcg pregnancy rapid test the medicines and healthcare products regulatory agency (mhra) of the united kingdom has posted a medical device safety alert concerning nadal hcg pregnancy rapid test [item number: 142002; lot numbers: all], manufactured by nal von minden gmbh. this safety notice concerns the limitations of the nadal hcg pregnancy rapid test, which is calibrated for intact hcg and detects intact hcg only. the proportions of intact hcg and other hcg forms in serum and urine may differ according to the stage of pregnancy in which it is analysed. according to the manufacturer, in rare cases, at a more advanced stage of pregnancy (approximately week 5-8 of pregnancy), increased amounts of hcg-beta-core fragments may be present in the urine hindering the detection reaction and leading to false negative results in spite of high hcg concentration. customers are advised to pay attention to this further limitation when evaluating the test result. for details, please refer to the mhra website: https://www.Gov.Uk/drug-device-alerts/field-safety-notices-19-december-23-december-2016 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 4 january 2017.

Device

NADAL hCG Pregnancy rapid test
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Nal von minden NADAL hCG Pregnancy rapid test
  • Manufacturer
    nal von minden GmbH

Manufacturer

nal von minden GmbH