Events

Alerta De Seguridad para BD BBL DrySlide PYR Kit and BD BBL DrySlide Oxidase Kit

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

¿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
    2013-04-26
  • Fecha de publicación del evento
    2013-04-26
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130426c.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 dryslide pyr kit and bd bbl dryslide oxidase kit medical device manufacturer, bd, has issued a field safety notice concerning bbl dryslide pyr kit (catalogue number: 231747, lot number: 2276481) and bbl dryslide oxidase kit (catalogue number: 231746, lot number: 2222008). bd has confirmed through complaint investigation that during the manufacturing process portions of the test slides in the above referenced products were placed into the incorrect product packaging. this could result in intermittent quality control failures and false results. the manufacturer advises to discontinue and discard affected products and product replacement can be arranged. according to the local supplier, the affected products were distributed in hong kong. if you are in possession of the products, please contact your supplier for necessary actions. posted on 26 april 2013.

Device

BD BBL DrySlide PYR Kit and BD BBL DrySlide Oxidase Kit
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: BD BBL DrySlide PYR Kit and BD BBL DrySlide Oxidase Kit
  • Manufacturer
    BD

Manufacturer

BD