Events

Notificaciones De Seguridad De Campo acerca de Immunoassay Control

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 Randox.

¿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
    2015-08-20
  • 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 are currently investigating an issue with the products listed below and are providing this urgent field safety notice to inform you of this occurrence. detail on affected devices: immunoassay control ia2640 lot 1364ec and immunoassay premium plus control ia3112 batch 334337 lot 1364ec. description of the problem: pth stability has been reduced in control lot 1364ec. it is now recommended that pth is tested immediately after reconstitution. risk to health: the contents of this letter should be discussed with your medical director. it is unlikely the error will cause misreporting of patient results as values for pth using this lot would fall outside of the assigned ranges. .

Device

Immunoassay Control
  • Modelo / Serial
    Immunoassay Control – IA2640 – 1364EC Immunoassay Premium Plus Control – IA3112 – 334337 –1364EC
  • Manufacturer
    Randox

Manufacturer

Randox