Events

Versant kPCR Molecular System Sample Preparation 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Siemens Healthcare 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-2016-RN-00327-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2016-03-21
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00327-1
  • 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
    An issue has been identified regarding an unintended behaviour of the system's result-generation software. it has been observed that an internal control displayed a no baseline error but the assay result for that well was not reported as an invalid result. the correct software behaviour is to report the assay result as invalid result when the internal control for that well displays a no baseline error. this issue allows for the possibility that an incorrect assay result could be reported for a sample when the result should be invalid and the sample repeated. there is an extremely low risk of false negative results.
  • 조치
    Siemens is advising users to review each report for the affected Versant IVD assays to identify if there are any No Baseline errors in the IC channel of any wells. If a No Baseline error occurs for the Internal Control of any well, users must not report the assay result for that well and repeat the test. A review of previously generated results is at the discretion of the Laboratory Director.

Device

Versant kPCR Molecular System Sample Preparation
  • 모델명 / 제조번호(시리얼번호)
    Versant kPCR Molecular System Sample PreparationAffected Assays: HIV-1 RNA 1.5, HBV DNA 1.0, HCV RNA 1.0, CT/GC DNA 1.0 Siemens Material Number (SMN): 10282928All serial numbers affectedARTG Number: 175890An in vitro diagnostic medical device (IVD)
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

Siemens Healthcare Pty Ltd