Events

Retiro De Equipo (Recall) de Device Recall QuantiFERON TBGold

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Qiagen Sciences LLC.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    73384
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1230-2016
  • Fecha de inicio del evento
    2016-02-02
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-08-16
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=143995
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Test, immunity, cell mediated, mycobacterium tuberculosis - Product Code NCD
  • Causa
    Potential for obtaining a false positive result due to the possibility of endotoxin presence.
  • Acción
    QIAGEN sent an "Urgent - Notification of Market Withdrawal" dated February 2, 2016, to all affected customers. The letter identify the product the problem and the action needed to be taken by the customer. Immediately discontinue use of this lot and discard any remaining inventory. Please acknowledge receipt of this notification and actions taken by completing the information on the next page, and return to: TechService-NA@qiagen.com or fax +1-661-775-7479. QIAGEN apologizes for any inconvenience this market withdrawal has caused, and continues to take every effort possible to ensure the highest quality of product is always available to our valued customers around the globe. Please do not hesitate to contact your local QuantiFERON sales representative or customer service representative should you have any questions or concerns. For further questions, please call ( 240) 686-7500.

Device

Device Recall QuantiFERON TBGold
  • Modelo / Serial
    CODE(S):   a. Cat # 0592-0201 Lot #A150135A TB Antigen Tube Expiry: April 2016  b. Cat # 0590-0201 Lot #059061291 TB-Nil 200pk Expiry: April 2016  c. Cat # 0597-0201 Lot #059772271 SPP Expiry: April 2016  d. Cat # 0597-0701 Lot #059772281 SPP-Luer Expiry: April 2016  e. Cat # 622686 Lot #059087361 TB-Nil 200 PK Expiry: April 2016
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US Distribution to the state of : Georgia., and to the countries of : Austria, Belgium, Switzerland, Czech Republic, Germany, Denmark, Estonia, Spain, France, Great Britain, Ireland, Korea (South) Luxembourg, Netherlands, Poland, Portugal, Qatar, Russian (Federation), Singapore, Turkey and South Africa.
  • Descripción del producto
    QFT TB Antigen Tube. || QIAGEN Sciences, LLC. The QuantiFERON TB-Gold is an indirect test for M. tuberculosis infection (including disease)
  • Manufacturer
    Qiagen Sciences LLC

Manufacturer

Qiagen Sciences LLC
  • Dirección del fabricante
    Qiagen Sciences LLC, 19300 Germantown Rd, Germantown MD 20874-1415
  • Empresa matriz del fabricante (2017)
    QIAGEN N.V.
  • Source
    USFDA