Events

QuantiFERON 에 대한 현장 안전성 서한

Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI)에 따르면, 해당 현장 안전성 서한 는 Slovenia 에서 QIAGEN GmbH 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

현장 안전성 서한은 의료기기 제조사 또는 제조사 대리인이 시중에 유통되고 있는 자사 의료기기 제품에 대하여 취할 수 있는 조치를 알리는 소통방식입니다. 주요 대상층은 보건의료업계 종사자와 의료기기 사용자들입니다. 여기에는 회수(recall) 조치와 경고도 포함될 수 있습니다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Field Safety Notice
  • 날짜
    2016-02-26
  • 사례 국가
    Slovenia
  • 사례 출처
    AMPMDRS
  • 비고 / 경고
    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.
  • 데이터 추가 비고
  • 원인
    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 in an abundance of caution the remainder of this lot is being withdrawn.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
  • 모델명 / 제조번호(시리얼번호)
    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