Events

Retiro De Equipo (Recall) de Quantiferon (QFT) Gold Tubes, QFT Gold Unitised Pack, TB Ag Tubes 100ct, QFT Gold Tubes (Nil & TB & Mitogen) High Altitude. An in vitro diagnostic medical device (IVD).

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Cellestis Ltd.

¿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
    RC-2012-RN-01065-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2012-10-22
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-01065-1
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Notas adicionales en la data
  • Causa
    Reports of higher than expected rate of quantiferon (qft) tb gold positive results from lot # a111103n have been received; cellestis initiated an investigation into the situation and confirmed the findings with the identification of 4 positive results from 17 persons who tested negative using several other lots of tubes. cellestis conducted a review of the manufacturing process and identified the potential contamination of lot # a111103m (high altitude) and a portion of tubes from lot #a111103m.This recall action was not notified to the tga before it was initiated by cellestis ltd.
  • Acción
    The sponsor is asking all user to discontinue use and dispose of current stock. Customers are advised that is unexpected positive results have been obtained using the affected tubes, results should be considered in light of all clinical information. Patient re-testing using a different Lot of QFT TB-Antigen tubes should be considered. If a re-test is required, Cellestis will provide a replacement.

Device

Quantiferon (QFT) Gold Tubes, QFT Gold Unitised Pack, TB Ag Tubes 100ct, QFT Gold Tubes (Nil & TB...
  • Modelo / Serial
    Quantiferon (QFT) Gold Tubes, QFT Gold Unitised Pack, TB Ag Tubes 100ct, QFT Gold Tubes (Nil & TB & Mitogen) High Altitude. An in vitro diagnostic medical device (IVD).QFT Gold TubesProduct Number: 0590-0201Lot Number: 059080251QFT Gold Unitised PackProduct Number: T0597-0403Lot Number: 059780251TB Ag Tubes 100ctProduct Code: T0592-0201Lot Number: 059280281QFT Gold Tubes (Nil & TB & Mitogen) High Altitude (HA)Product Code: T0590-0505Lot Number: 059090081
  • Manufacturer
    Cellestis Ltd

Manufacturer

Cellestis Ltd