Events

Recall of 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).

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Cellestis Ltd.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    RC-2012-RN-01065-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2012-10-22
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-01065-1
  • Notes / Alerts
    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.
  • Extra notes in the data
  • Reason
    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.
  • Action
    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...
  • Model / 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