Events

Notificaciones De Seguridad De Campo acerca de DiaMed Q.C. System

Según Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), este evento ( notificaciones de seguridad de campo ) involucró a un dispositivo médico en Slovenia que fue producido por Bio-Rad.

¿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
    2017-09-06
  • País del evento
    Slovenia
  • Fuente del evento
    AMPMDRS
  • Notas / Alertas
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
  • Notas adicionales en la data
  • Causa
    We have been made aware that samples of the product diamed q.C. system, ihd lot n° 45950 46 1 and 45950 47 1 show excessive hemolysis in samples 1 and 4 and weakly in sample 2. a risk assessment has been performed and no patient risk has been identified. you may continue to use the hemolysed cells äs lang äs they give the expected results and we kindly ask you to scrap all remaining kits of these above mentioned lots äs soon äs you get the replacement lots. tests have been performed internally and we can confirm that currently a clear result is returned with manual testing and on the saxo- swing, ih-1000 with the hemolysed qc samples. with ih-500 we may observe uninterpretable results on reverse grouping. in this case, please use another sample to perform the reverse grouping. note: tests involving serum 1 and serum 2 are in no way affected.

Device

DiaMed Q.C. System
  • Modelo / Serial
    Mat. n° 45950 Lot No IHD 45950 46 1 45950471 Lot No SAP 166035461 172383471 Expiry Date 25.09.2017 09.10.2017
  • Manufacturer
    Bio-Rad

Manufacturer

Bio-Rad