Events

Notificaciones De Seguridad De Campo acerca de QuantiFERON

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 QIAGEN GmbH.

¿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
    2016-02-26
  • 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
    During production of said lot of tb-antigen blood collection tubes, a portion did not meet endotoxin specification and was scrapped. the remaining portion was released upon additional testing and packaged in the above mentioned lot numbers of two kit configurations. qiagen has subsequently changed procedures on the release of tb-antigen blood collection tubes and identified said lot as the only remaining lot that was partially released that has not yet expired. to date, there has been no evidence of product performance being impacted for this lot. however we cannot dismiss the potential for an elevated rate of positivity due to increased endotoxin. in an abundance of caution the remainder of this lot is being withdrawn. no other lots are impacted. .

Device

QuantiFERON
  • Modelo / Serial
    QuantiFERON ® -TB Gold (QFT ® ) TB-Antigen blood collection tubes – LOT A150135A 0590-0201 QFT Tubes (100xNil,100xTBAg) 059061291 0597-0201 QFT Single Patient Pack (pack of 10) 059772271
  • Manufacturer
    QIAGEN GmbH

Manufacturer

QIAGEN GmbH
  • Empresa matriz del fabricante (2017)
    QIAGEN N.V.
  • Source
    AMPMDRS