Events

Alerta De Seguridad para Complement Control Cells, lot 34161

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

¿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
    2011-10-24
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20111023.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
    Field safety notice: immucor gamma complement control cells, lot 34161 medical device supplier, uninet technology ltd, issued an urgent product recall concerning complement control cells, lot 34161. complement control cells is a blood blank quality control reagent used to confirm the reactivity of the anti-c3 component of anti-human globulin. post-release testing on the complement control cells, lot 34161, has confirmed reports of weakened reactivity and negative results when using the product. immucor gamma requests customers stop using this lot and discard any remaining inventory. according to the local supplier, the affected product has distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions.

Device

Complement Control Cells, lot 34161
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Immucor Gamma Complement Control Cells, lot 34161
  • Manufacturer
    Immucor Gamma

Manufacturer

Immucor Gamma