Events

Alerta De Seguridad para ACL TOP Family Coagulation Systems

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

¿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
    2013-07-25
  • Fecha de publicación del evento
    2013-07-25
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130725a.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: werfen acl top family coagulation systems it has come to our attention that the medical device manufacturer, werfen group, instrumentation laboratory has initiated a medical device field safety corrective action concerning acl top family coagulation systems. the affected models are acl top, acl top cts, acl top 700, acl top 700 cts, acl top 700 las, acl top 500 cts and acl top 300 cts. it has come to our attention that the medical device manufacturer, werfen group, instrumentation laboratory has initiated a medical device field safety corrective action concerning acl top family coagulation systems. the affected models are acl top, acl top cts, acl top 700, acl top 700 cts, acl top 700 las, acl top 500 cts and acl top 300 cts. the extent of the shortened clotting times varies from instrument to instrument and is not reproducible on all instruments. in certain instances, this issue has manifested itself as a downward shift in aptt clotting times of greater than 10 seconds. the manufacturer is working on a software mitigation to address this issue. until available, the manufacturer advises users use the workaround described in the field safety notice. according to the local supplier, 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 25 july 2013.

Device

ACL TOP Family Coagulation Systems
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Werfen ACL TOP Family Coagulation Systems
  • Manufacturer
    Werfen Group

Manufacturer

Werfen Group