Events

Alerta De Seguridad para BRAHMS Neopterin EIA

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

¿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
    2015-10-22
  • Fecha de publicación del evento
    2015-10-22
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20151022b.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: thermo fisher scientific brahms neopterin eia medical device manufacturer, thermo fisher scientific, has issued a field safety notice regarding the brahms neopterin eia. the details of the affected device are shown below: kit reference number: 99.1 lot number (expiry date): 703449 (16 october 2015) and 703450 (8 january 2016) the manufacturer informs that for the brahms neopterin eia lot 703449 and lot 703450 the“quality control report”, which is included in the kit, contains an incorrect range for the quality control k2. this might lead to validating a run, which in fact was invalid. the manufacturer advises affected users to take the following actions:- stop using the incorrect quality control range for k2 contained in brahms neopterin eia, lot 703449 and lot 703450 use the correct quality control range for k2 contained in brahms neopterin eia, lot 703449 and lot 703450 provided by the manufacturer. re-evaluate all runs, which showed a value for quality control k2 between 44.4 nmol/l and 60.4 nmol/l. according to the local supplier, the affected product is distributed in hong kong. if you are in possession of the product, please contact your supplier for necessary actions. posted on 22 october 2015.

Device

BRAHMS Neopterin EIA
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Thermo Fisher Scientific BRAHMS Neopterin EIA
  • Manufacturer
    Thermo Fisher Scientific

Manufacturer

Thermo Fisher Scientific