Events

Alerta De Seguridad para Oxoid Antimicrobial Susceptibility Testing Disc CPD10 (Cefpodoxime)

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

¿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
    2013-02-06
  • Fecha de publicación del evento
    2013-02-06
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130206a.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: thermo fisher scientific oxoid antimicrobial susceptibility testing disc cpd10 (cefpodoxime) medical device manufacturer, thermo fisher scientific issued a medical device safety alert concerning oxoid antimicrobial susceptibility testing disc cpd10 (cefpodoxime) with model number ct1612b and lot number 1275353. according to the manufacturer, a technical investigation has indicated that the affected lot may contain individual discs that are not impregnated with antibiotic. continued use of this lot could result in false indication of resistance to cefpodoxime. after risk assessment, the manufacturer believes the clinical risk of a blank cefpodoxime disc is low. the manufacturer advised the affected customers to: stop using this lot; destroy any remaining stock; review results reported using this lot; and consider retesting and/or seek appropriate expert advice. the manufacturer confirmed that the affected products have been distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 06 february 2013.

Device

Oxoid Antimicrobial Susceptibility Testing Disc CPD10 (Cefpodoxime)
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Thermo Fisher Scientific Oxoid Antimicrobial Susceptibility Testing Disc CPD10 (Cefpodoxime)
  • Manufacturer
    Thermo Fisher Scientific

Manufacturer

Thermo Fisher Scientific