Alerta De Seguridad para MagNA Pure 24 System

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 magna pure 24 system medical device manufacturer, roche diagnostics, has issued a medical device safety alert concerning its magna pure 24 system [gmmi number: 7290519001]. cross-contamination of samples has been reported, by an external collaborator, when running the existing pathogen200 protocol on the magna pure 24 system. the manufacturer’s internal investigation has confirmed the issue for the launched pathogen200 and pathogen1000 protocols. the cross-contamination of samples during pathogen nucleic acid extraction can create false positive or over-quantified results, which may result in exposure to unnecessary medication side effects or medical procedures that have a remote probability of creating adverse health consequences. according to the manufacturer, cross-contamination is caused by a too low offset value for magnetic glass particle (mgp) pre-dispensing to the reagent wells of the processing cartridge. reagent wells on the processing cartridge are used to pre-dispense all reagents. processing tips transfer reagents to the samples in the processing wells of the processing cartridge. the processing tips used for this transfer have already been in contact with the sample material and therefore contaminate the remaining liquid in the reagent wells. in most cases, laboratories do not need to review previous results or retest patients because cross contamination and the generation of false positive results are likely to be quite rare and require the presence of a high titer source sample. a review of previous results would only be relevant in cases where the magna pure 24 pathogen protocols (200 and/or 1000) were used to extract nucleic acids for an assay for a chronic infectious disease (e.G., hepatitis c) and a change in result reporting could impact patient management. suspected false positives that could potentially affect patient management should be retested according to local procedures, using either the magna pure 24 instrument with the newly launched pathogen200 hp or fast pathogen 200 protocols or external lysis pathogen 200 and 500 protocols or an alternative method. the affected users are advised to take the following actions until the updated pathogen200 and pathogen1000 protocols are available: utilize the newly launched pathogen200 hp or fast pathogen 200 protocols or external lysis pathogen 200 and 500 protocols; utilize an alternative method for testing purposes according to the local supplier, the affected product is distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 2 may 2018.


  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Roche Diagnostics MagNA Pure 24 System
  • Manufacturer