Events

Alerta De Seguridad para chromID S. aureus agar

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

¿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
    2013-08-08
  • Fecha de publicación del evento
    2013-08-08
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130808.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: biomérieux chromid s. aureus agar medical device manufacturer, biomérieux, has issued a medical device safety alert concerning certain lots of chromid s. aureus agar [catalogue no.: 43371; lot no.: all]. the manufacturer detected a sensitivity issue on chromid s. aureus agar (said) reference 43371: weak growth of staphylococcus aureus with a non-characteristic color at 24 hours from specimen samples or s. aureus atcc 25923 (quality control strain). the potential risk associated to this issue is reporting false negative results at 24 hours. as the package insert requires the identification of all colonies other than green ones (white, pink or mauve), s. aureus with a non-characteristic color will be systematically detected. according to the manufacturer’s investigation results, a modification of the package insert will be implemented. according to the local supplier, the affected products were distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 8 august 2013.

Device

chromID S. aureus agar
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: BioMérieux chromID S. aureus agar
  • Manufacturer
    BioMérieux

Manufacturer

BioMérieux