Events

Alerta De Seguridad para BD BBL Crystal Enteric/Nonfermenter ID Kit

Según Department of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Hong Kong que fue producido por BD 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
    2012-12-28
  • Fecha de publicación del evento
    2012-12-28
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20121228.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 crystal enteric/nonfermenter id kit medical device manufacturer, bd diagnostic systems, has issued a medical device safety alert concerning bbl crystal enteric/nonfermenter id kit. the affected catalogue number is 245000 and the affected lot numbers are 2086315, 2101435, 2104316, 2129460, 2129487, 2163211, 2163213, and 2163215. bd has determined through complaint investigation that the above referenced products have the citrate (cit) and malonic acid (mlo) reagents in the reversed prong/well positions. this may lead to no-identification or multiple identification choices. customers specifically reported split identification results between citrobacter and salmonella; however, other bacterial identifications requiring the use of these two substrates may also be affected. according to the local supplier, the affected products have been distributed in hong kong. bd advised the affected customers to discontinue use of the affected lots and discard any remaining packages. if you are in possession of the products, please contact your supplier for necessary actions. posted on 28 december 2012.

Device

BD BBL Crystal Enteric/Nonfermenter ID Kit
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: BD BBL Crystal Enteric/Nonfermenter ID Kit
  • Manufacturer
    BD Diagnostic Systems

Manufacturer

BD Diagnostic Systems