Events

ADVIA Chemistry Theophylline_2 Reagent 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-00831-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2016-06-27
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00831-1
  • 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
    Siemens healthcare diagnostics has identified that the advia chemistry theophylline_2 (theo_2) reagent lot 334018 used on the advia 1200, 1800, 2400, and xpt chemistry systems may exhibit increased imprecision for commercially available tdm quality controls and patient specimens.Siemens internal investigation after one internal complaint was received confirmed that reagent lot 334018 is not in statistical alignment with the representative precision data published in the ifu and the design input requirements on the advia chemistry systems.Discordance with the clinical presentation is expected to lead to repeat testing or more frequent monitoring. there may be a delay in theophylline testing due to troubleshooting after failed qc.
  • 조치
    Siemens is advising users to discontinue use of and discard the kit lot. Siemens is recommending that a review of previously generated results is considered.

Device

ADVIA Chemistry Theophylline_2 Reagent
  • 모델명 / 제조번호(시리얼번호)
    ADVIA Chemistry Theophylline_2 ReagentTest Code: THEO_2Catalogue Number: 10377503Lot Number: 334018Expiration Date: Sept 2017ARTG Number: 175699An in vitro diagnostic medical device (IVD)
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

Siemens Healthcare Pty Ltd