Alerta De Seguridad para elecsys anti-hav

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

¿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
  • Fecha de publicación del evento
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • 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 diagnostics elecsys anti-hav medical device manufacturer, roche diagnostics, has issued a field safety notice concerning its elecsys anti-hav [device identifier: 04854977190; lot number: all]. the manufacturer has determined that the performance of the elecsys anti-hav assay is impacted by certain types of plasma specimens. therefore, the claim in the method sheet regarding acceptable specimens under ‘specimen collection and preparation’ will be corrected. li- and na-heparin specimens will no longer be acceptable specimen types. according to the manufacturer, when li-heparin and na-heparin plasma specimens were compared to serum samples during internal investigations the specified required recovery could not be achieved. if li-heparin or na-heparin plasma specimens are used, erroneous negative anti-hav results are possible. taking into consideration the high frequency of occurrence and difficult detectability of the issue, a relevant medical risk cannot be excluded. on the other hand, internal investigations have determined that the usage of k3-edta plasma specimens does not carry the risk of generating erroneous results. the manufacturer advises affected users to consider the limitations of the new ‘specimen collection and preparation’ wording in the assay instructions as listed in the field safety notice. in case users suspect discrepant results with li- and na-heparin plasma specimens or have specific questions, re-testing might be advisable in concordance with relevant clinical information. according to the local supplier, the affected products are distributed in hong kong. the medicines and healthcare products regulatory agency (mhra) of the united kingdom has also posted a medical device safety alert concerning similar issue. for details, please refer to the mhra website: https://www.Gov.Uk/drug-device-alerts/field-safety-notices-30-january-3-february-2017 if you are in possession of the products, please contact your supplier for necessary actions. posted on 8 february 2017.


  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Roche Diagnostics Elecsys Anti-HAV
  • Manufacturer