Events

Safety Alert for Quantiferon-TB Gold

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by QIAGEN || Importer: QUIMIOLAB LTDA.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    RRD-030316
  • Event Number
    INVIMA 2012RD-0002301
  • Date
    2016-03-07
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=153
  • Notes / Alerts
    Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 Colombia.
  • Extra notes in the data
  • Reason
    Voluntary withdrawal of the blood collection tubesquantiferon-tb gold tb-antigen, identified with lota150135a, which are part of the kits previously referred. during the manufacture of these tubes, a quantity of endotoxin that did not meet the quality specifications was discarded and the remaining portion, after being subjected to additional tests, was partially released. lacasa parent company qiagen has changed the deliberation procedures of said tubes and has identified that the lot a150135a that was partially released has not yet expired. to date there has been no evidence that the performance of the product is affected for this lot, however, no the possibility of a high positivity due to the increase in endotoxin may be ruled out.

Device

Quantiferon-TB Gold
  • Model / Serial
    Lot of tubes: A150135A || R eference: 0590-0201; Lot: 059061291 || Reference: 0597-0201; Lot: 059772271 || Reference: 0597-0701; Lot: 059772281
  • Product Description
    INDIRECT TEST FOR THE DETECTION OF M. TUBERCULOSIS INFECTION
  • Manufacturer
    QIAGEN || Importer: QUIMIOLAB LTDA

Manufacturer

QIAGEN || Importer: QUIMIOLAB LTDA
  • Manufacturer Parent Company (2017)
    QIAGEN N.V.
  • Source
    NIDFSINVIMA