Events

Field Safety Notices about QuantiFERON

According to Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), this field safety notices involved a device in Slovenia that was produced by QIAGEN GmbH.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Field Safety Notice
  • Date
    2016-02-26
  • Event Country
    Slovenia
  • Event Source
    AMPMDRS
  • Notes / Alerts
    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.
  • Extra notes in the data
  • Reason
    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 in an abundance of caution the remainder of this lot is being withdrawn.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
  • Model / Serial
    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