Events

Alerta De Seguridad para BD BBL Fildes Enrichment

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

¿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
    2013-01-17
  • Fecha de publicación del evento
    2013-01-17
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130117.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: bd bbl fildes enrichment medical device manufacturer, bb diagnostic systems, has initiated a field safety corrective action concerning bd bbl fildes enrichment [catalogue no.: 211866; lot no.: 2079066, 2096375, 2216092, 2227271]. the manufacturer has determined through complaint investigation that the above-referenced lot numbers of product are failing to support the growth of haemophilus species. the affected users are advised to discontinue use and discard any remaining products. due to an anticipated delay for the available of fildes enrichment, the manufacturer will substitute difco supplement b with reconstituting fluid (catalogue no. 227610-6 x 10ml) as the replacement product. according to the local supplier, the affected products were distributed in hong kong. if you are in possession of the product, please contact your supplier for necessary actions. posted on 17 january 2013.

Device

BD BBL Fildes Enrichment
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: BD BBL Fildes Enrichment
  • Manufacturer
    BB Diagnostic Systems

Manufacturer

BB Diagnostic Systems