Events

Xpert CT/NG Assay. An in vitro diagnostic medical device (IVD) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Cepheid Holdings 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-2017-RN-00375-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2017-03-21
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00375-1
  • 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
    Reports have been received that some customers have experienced a higher number of invalid results than would typically be expected when using the xpert ct/ng assay and its intended use specimen types. this could lead to the need to retest and consequently, a delay in test results and subsequent treatment.
  • 조치
    Cepheid is advising users to discontinue use and discard affected stock in their inventory. Users are further advised to acknowledge receipt of the recall letter and return it to Cepheid customer service in order to receive replacement stock.

Device

Xpert CT/NG Assay. An in vitro diagnostic medical device (IVD)
  • 모델명 / 제조번호(시리얼번호)
    Xpert CT/NG Assay. An in vitro diagnostic medical device (IVD)Catalogue Number: GXCT/NG-CE-10Lot Number: 100044234Cartridge Lot Number: 11715Expiration Date: 29 July 2018ARTG Number: 207540
  • Manufacturer
    Cepheid Holdings Pty Ltd

Manufacturer

Cepheid Holdings Pty Ltd