Events

Notificaciones De Seguridad De Campo acerca de ACL TOP 300 CTS, HemosIL SynthasIL

Según ALIMS (Agencija za lekove i medicinska sredstva), este evento ( notificaciones de seguridad de campo ) involucró a un dispositivo médico en Serbia que fue producido por Instrumentation Laboratory Co..

¿Qué es esto?

Las notificaciones de seguridad de campo son comunicaciones sobre acciones que se pueden estar tomando en relación con un producto que se encuentra en el mercado, enviadas por los fabricantes de dispositivos médicos o sus representantes. Estas notificaciones son principalmente para trabajadores de la salud, pero también para usuarios. Pueden incluir alertas y retiro de equipos.

Más información acerca de la data acá
  • Tipo de evento
    Field Safety Notice
  • Fecha de publicación del evento
    2013-10-23
  • País del evento
    Serbia
  • Fuente del evento
    ALIMSA
  • URL de la fuente del evento
    https://www.alims.gov.rs/latin/2013/10/23/%d0%b2%d0%b0%d0%b6%d0%bd%d0%be-%d0%be%d0%b1%d0%b0%d0%b2%d0%b5%d1%88%d1%82%d0%b5%d1%9a%d0%b5-%d0%be-%d0%bc%d0%b5%d0%b4%d0%b8%d1%86%d0%b8%d0%bd%d1%81%d0%ba%d0%b8%d0%bc-%d1%81%d1%80%d0%b5%d0%b4%d1%81/
  • Notas / Alertas
    Serbian data is current through February 2018. All of the data comes from ALIMS (Agencija za lekove i medicinska sredstva), 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 recall data from the U.S. and Serbia.
  • Notas adicionales en la data
  • Causa
    The manufacturer's research has shown that a carryover tool may occur on an instrument in the acl top analyzer family that causes a shortening of the "aptt" time in patient samples and / or control samples when the hemosil synthasil reagent (pn 0020006800) is placed on the same reagent carrier , together with some other hemosil reagents. interference occurs during the liquid height check (liquid height check) that is performed after mounting the supports and depends on the position of the material, the order in which the supports are placed and the order in which the tests are performed. the degree of shortening of coagulation time varies from instrument to instrument and is not reproducible on all instruments. in some cases, this problem manifested as shortening the "aptt" time by more than ten seconds.

Device

ACL TOP 300 CTS, HemosIL SynthasIL

Manufacturer

Instrumentation Laboratory Co.