Events

Retiro De Equipo (Recall) de QuantiFERON TB Gold TB High Altitude (HA)Blood Collection Tubes

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 Cellestis Inc.

¿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
    64228
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0889-2013
  • Fecha de publicación del evento
    2013-02-26
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-04-25
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=115630
  • 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
    Cellestis is recalling quantiferon¿¿ - tb gold tb blood collection tubes and ha tb blood collection tubes due to potential contamination.
  • Acción
    Cellestis, inc., sent a "Notification of market withdrawal of QuantiFERON¿" letter dated September 27, 2012 to its domestic and international customers. The letter described the product, problem and actions to be taken. The customers were informed to discontinue use of these products and any product sequestered such that it cannot be used or distributed. Cellestis will provide replacement materials, if and when a retest is required. Please do not hesitate to contact your local QuantiFERON sales representative or customer service representative at +613 8527 3500 or 661-775-7480 should you have any questions or concerns.

Device

QuantiFERON TB Gold TB High Altitude (HA)Blood Collection Tubes
  • Modelo / Serial
    Cat # 0592-0501; Lot A111103M; Exp 28 FEB, 2013
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution: USA (nationwide) and countries of: Argentina, Australia, Austria, Belgium, Bosnia and Herzegovina, Bulgaria, Czech Republic, Denmark, Estonia, Finland, France, Germany, Great Britain, Ireland, Israel, Jordan, Luxembourg, Mexico, Netherlands, New Zealand, Peru, Poland, Saudi Arabia, Slovakia, Slovenia, South Africa, Switzerland, and Turkey.
  • Descripción del producto
    Vacuette Cellestis 1 ml QuantiFERON¿ TB ANTIGEN (HA) High Altitude: Shake 10x; REF 454413. HE0396. greiner bio-one; 13x75 50pcs.,1200 pcs in total. || Product Usage: QuantiFERON¿-TB Gold (QFT) is an in vitro diagnostic test using a peptide cocktail simulation ESAT-6, CFP-10 and TB7.7 (p4) proteins to stimulate cells in heparinized whole blood.
  • Manufacturer
    Cellestis Inc

Manufacturer

Cellestis Inc
  • Dirección del fabricante
    Cellestis Inc, 28358 Constellation Rd Ste 698, Santa Clarita CA 91355-5044
  • Empresa matriz del fabricante (2017)
    QIAGEN N.V.
  • Source
    USFDA