Events

Avis De Sécurité sur QuantiFERON

Selon Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), ce/cet/cette avis de sécurité concerne un dispositif en/au/aux/à Slovenia qui a été fabriqué par QIAGEN GmbH.

Qu'est-ce que c'est?

Les avis de sécurité sont des communications que les fabricants de dispositifs médicaux ou leurs représentants font parvenir en particulier aux travailleurs du secteur médical, mais aussi aux utilisateurs de ces dispositifs. Les avis de sécurité concernent les actions entreprises quant aux dispositifs présents sur le marché et peuvent inclure des rappels et des alertes.

En savoir plus sur les données ici
  • Type d'événement
    Field Safety Notice
  • Date
    2016-02-26
  • Pays de l'événement
    Slovenia
  • Source de l'événement
    AMPMDRS
  • Notes / Alertes
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
  • Notes supplémentaires dans les données
  • Cause
    During production of said lot of tb-antigen blood collection tubes, a portion did not meet endotoxin specification and was scrapped. the remaining portion was released upon additional testing and packaged in the above mentioned lot numbers of two kit configurations. qiagen has subsequently changed procedures on the release of tb-antigen blood collection tubes and identified said lot as the only remaining lot that was partially released that has not yet expired. to date, there has been no evidence of product performance being impacted for this lot. however we cannot dismiss the potential for an elevated rate of positivity due to increased endotoxin. in an abundance of caution the remainder of this lot is being withdrawn. no other lots are impacted. .

Device

QuantiFERON
  • Modèle / numéro de série
    QuantiFERON ® -TB Gold (QFT ® ) TB-Antigen blood collection tubes – LOT A150135A 0590-0201 QFT Tubes (100xNil,100xTBAg) 059061291 0597-0201 QFT Single Patient Pack (pack of 10) 059772271
  • Manufacturer
    QIAGEN GmbH

Manufacturer

QIAGEN GmbH