Events

Alerta De Seguridad para Access BR Monitor

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

¿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
    2017-04-18
  • Fecha de publicación del evento
    2017-04-18
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20170418a.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: beckman coulter access br monitor medical device manufacturer, beckman coulter, has issued a medical device safety alert concerning its access br monitor for use with the access family of immunoassay systems [reference 387620; all non-expired lots and future lots]. following biases observed in the results of the french national quality controls, the manufacturer has been informed that a study completed by the french competent authority agence nationale de sécurité du medicament et des produits de santé (ansm) showed diagnosed cancer patients in non-remission of their metastatic disease, may have results below the upper reference limit (url) of 31.3 u/ml as stated in the access br monitor instructions for use (ifu). according to the manufacturer, the ansm’s preliminary study demonstrated that 10 out of 27 patients diagnosed with cancer in non-remission had a result below the access br monitor url. the manufacturer is evaluating the access br monitor cutoff. the conclusions of this evaluation are planned by the third quarter of 2017. affected users are advised to ensure their laboratory staff and clinicians are aware of the limitations of the access br monitor assay found in the ifu. 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 18 april 2017.

Device

Access BR Monitor
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Beckman Coulter Access BR Monitor
  • Manufacturer
    Beckman Coulter

Manufacturer

Beckman Coulter