Events

Alerta De Seguridad para VIDAS Cortisol S

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

¿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
    2014-10-28
  • Fecha de publicación del evento
    2014-10-28
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20141028a.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: biomérieux vidas cortisol s medical device manufacturer, biomérieux, has issued a medical device safety alert concerning its vidas cortisol s. the affected product number is 30451 and the affected lot number is 1003380350. an error occurred during the manufacturing process of vidas cortisol s kits (ref. 30451, lot 1003380350). the quantity of one of the raw material present in the composition of the conjugate buffer (well 5 of the vidas cortisol s strips ref. 30451 lot 1003380350). according to the manufacturer, the identified discrepancy does not affect product performance nor does it pose any health and safety risk to the end user. the manufacturer advises users to discard any remaining inventory of the affected products and contact them for product replacement. according to the local supplier, the affected products were distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 28 october 2014.

Device

VIDAS Cortisol S
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: BioMérieux VIDAS Cortisol S
  • Manufacturer
    BioMérieux

Manufacturer

BioMérieux