Events

Alerta De Seguridad para NaOHD and Hitergent Cassettes

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

¿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
    2013-02-19
  • Fecha de publicación del evento
    2013-02-19
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130219a.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: roche naohd and hitergent cassettes medical device manufacturer, roche diagnostics gmbh issued a medical device safety alert concerning the following products: naohd (for c702)- catalogue no.: 05172128 190; lot no.: 669088 and 663099 hitergent (for c702)- catalogue no.: 05172101 190; lot no.: 666210 according to roche, some of the lots listed above may have micro-leakage. internal investigation revealed that the frequency of the micro-leakage showed in 1 out of 8000 cassettes.  users are suggested to check whether the cellophane wrapping of the cassettes are wet before loading to the reagent manager. according to roche, all further product lots will undergo a 100% leakage check during the manufacturing process, and reimbursement or replacement can be offered in case of product leaking. according to the local supplier, roche diagnostics (hong kong) limited, 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 19 february 2013.

Device

NaOHD and Hitergent Cassettes
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Roche NaOHD and Hitergent Cassettes
  • Manufacturer
    Roche Diagnostics GmbH

Manufacturer

Roche Diagnostics GmbH