Events

artus C. trachomatis Plus kits (used for the detection of plasmid free variants of Chlamydia trachomatis) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Qiagen Pty Ltd 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    RC-2015-RN-01117-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2015-11-16
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-01117-1
  • 비고 / 경고
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • 데이터 추가 비고
  • 원인
    The artus c. trachomatis plus kits are designed to detect a 106 bp region of the chlamydia trachomatis chromosome and a 111 pb region of the crypticplasmid of c. trachomatis; however, the kits fail to detect the chromosomal target. the kits do not detect cryptic-plasmid-free variants.Accordingly, qiagen will be amending the instructions for use of this product to remove the claim that the product can detect cryptic-plasmid free variants of c. trachomatis.
  • 조치
    QIAGEN is advising users to be aware that cryptic-plasmid-free variants of C. trachomatis are not detected by the kits. QIAGEN is advising a review of negative patient results is at the discretion of the Laboratory Manager. This action has been closed-out on 24/08/2016.

Device

artus C. trachomatis Plus kits (used for the detection of plasmid free variants of Chlamydia trac...
  • 모델명 / 제조번호(시리얼번호)
    artus C. trachomatis Plus kits (used for the detection of plasmid free variants of Chlamydia trachomatis)artus C. trachomatis Plus RG PCR Kit (24) CE - Cat. No. 4559263artus C. trachomatis Plus RG PCR Kit (96) CE - Cat. No. 4559265artus C. trachomatis Plus LC PCR Kit (24) CE - Cat. No. 4559063artus C. trachomatis Plus LC PCR Kit (96) CE - Cat. No. 4559065artus C. trach. PLUS RG PCR Kit (768) CE - Cat. No. 4559267An in vitro diagnostic medical device (IVD)
  • Manufacturer
    Qiagen Pty Ltd

Manufacturer

Qiagen Pty Ltd