Events

Alerta De Seguridad para Etest Ertapenem

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
    2014-02-12
  • Fecha de publicación del evento
    2014-02-12
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20140212.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 etest ertapenem medical device manufacturer, biomerieux, has issued a field safety notice concerning certain lots of the following products: etest ertapenem - foam etp 32 – 30 tests (reference: 531610); etest ertapenem- foam etp 32 – 100 tests (reference: 531618); etest ertapenem etp 32 – single pack of 30 tests (reference: 412332) the manufacturer identified a performance issue on the etest foam ertapenem (reference 531610 and 531618) and etest single pack ertapenem (reference 412332). these strips did not give the correct minimum inhibitory concentration (mic) for some of quality control strains. for non-enterobacteriaceae (quality control purpose), the mic shift over the time can be greater than +1 dilution when compared to the mics initially obtained at the time of the release. for enterobacteriaceae, the over-estimation of mic can change the category result of isolates having mic equal or close to the breakpoint. according to the manufacturer, this performance issue leading to this over-estimation of mic can be detected using the quality control as recommended in the etest package insert. the manufacturer advises users to discontinue using and to destroy the affected kits. it will provide replacement kits as soon as a new batch of etest ertapenem is available. 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 12 february 2014.

Device

Etest Ertapenem
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Biomerieux Etest Ertapenem
  • Manufacturer
    Biomerieux

Manufacturer

Biomerieux