Events

Alerta De Seguridad para Vitek 2 Gram Positive Susceptibility Test Cards

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

¿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
    2016-05-18
  • Fecha de publicación del evento
    2016-05-18
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20160518b.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: biomerieux vitek 2 gram positive susceptibility test cards the united states food and drug administration (fda) has issued a medical device safety alert concerning vitek 2 gram positive susceptibility test cards, manufactured by biomerieux. the affected devices are identified as follows:- (ast-p636 ref 417951), (ast-p639 ref 418662), (ast-p640 ref 418579), (ast-p641 ref 418590), (ast-p642 ref 418604), (ast-p643 ref 418671), (ast-p644 ref 418673), (ast-p645 ref 419602), (ast-p646 ref 420144) according to the fda, the product inserts fail to identify performance limitation related to eucast breakpoints for teicolplanin. for details, please refer to the fda website: http://www.Accessdata.Fda.Gov/scripts/ires/index.Cfm if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 18 may 2016.

Device

Vitek 2 Gram Positive Susceptibility Test Cards

Manufacturer

Biomerieux