Events

Alerte De Sécurité sur Quantiferon-TB Gold

Selon National Institute of Drugs and Food Surveillance (INVIMA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Colombia qui a été fabriqué par QIAGEN || Importer: QUIMIOLAB LTDA.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • ID de l'événement
    RRD-030316
  • Numéro de l'événement
    INVIMA 2012RD-0002301
  • Date
    2016-03-07
  • Pays de l'événement
    Colombia
  • Source de l'événement
    INVIMA
  • URL de la source de l'événement
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=153
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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
  • Modèle / numéro de série
    Lot of tubes: A150135A || R eference: 0590-0201; Lot: 059061291 || Reference: 0597-0201; Lot: 059772271 || Reference: 0597-0701; Lot: 059772281
  • Description du dispositif
    INDIRECT TEST FOR THE DETECTION OF M. TUBERCULOSIS INFECTION
  • Manufacturer
    QIAGEN || Importer: QUIMIOLAB LTDA

Manufacturer

QIAGEN || Importer: QUIMIOLAB LTDA
  • Société-mère du fabricant (2017)
    QIAGEN N.V.
  • Source
    NIDFSINVIMA