Events

LOCI Cardiac Troponin I Calibrator (used with Dimension EXL Clinical Chemistry Systems) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Siemens Ltd Diagnostics Division 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-2013-RN-00972-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2013-09-16
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00972-1
  • 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
    Internal testing has confirmed customer complaints regarding an upward shift in qc and patient results following calibration with loci cardiac troponin i calibrator lot 3dd007. based on initial internal investigation, siemens estimates that approximately 40% of the calibrator lot is affected. internal testing on patient samples demonstrated an average upward shift of 24% range when compared to an unaffected lot.
  • 조치
    Siemens is requesting their customers to immediately discontinue use and discard any remaining inventory from the affected lot. Siemens is recommending to discuss the issues and requirement for retesting with the medical director. The recommendations regarding the need to review previous QC and patient results is limited to samples tested within the past 24 hours.

Device

LOCI Cardiac Troponin I Calibrator (used with Dimension EXL Clinical Chemistry Systems)
  • 모델명 / 제조번호(시리얼번호)
    LOCI Cardiac Troponin I Calibrator (used with Dimension EXL Clinical Chemistry Systems)Catalogue Number: RC621Siemens Material Number: 10464336Lot Number: 3DD007ARTG Number: 1822774An in vitro diagnostic medical device (IVD)
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

Siemens Ltd Diagnostics Division