Events

Alerta De Seguridad para Campylosel agar

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

¿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
    2016-09-06
  • Fecha de publicación del evento
    2016-09-06
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20160906.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: biomerieux campylosel agar medical device manufacturer, biomerieux, has issued a medical device safety alert concerning its campylosel agar [reference number: 43361; lot number: 1004948090, 1004981930 and 1005023880]. based on a lack of selectivity issue reported on plates of the impacted lots of campylosel agar, the manufacturer initiated a complaint investigation to confirm product performance and determine root cause. while the investigation is still ongoing, the following have been identified: there is growth of a enterobacter cloacae strain isolated in a laboratory on the impacted lots of campylosel agar that could mask the growth of the campylobacter strain. this growth could lead to a misinterpretation of the results and therefore to a false negative result. the growth of this enterobacter cloacae strain on the impacted lots of campylosel agar could be explained by higher mic for aztreonam and cefoperazon antibiotics than usually. according to the manufacturer, immediate corrective action was implemented on 5 aug 2016 at the manufacturing site level to optimize campylosel agar manufacturing conditions by reducing the additive shelf-life when used for the manufacturing of campylosel agar. the users are advised to follow the instructions and implemented the actions as indicated in field safety notice according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 6 september 2016.

Device

Campylosel agar
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: BioMerieux Campylosel agar
  • Manufacturer
    BioMerieux

Manufacturer

BioMerieux