Events

ADVIA Chemistry Systems Lipase Assay 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-2015-RN-00269-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2015-03-26
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00269-1
  • 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 the potential for positive biase of advia chemistry systems lipase assay results due to carry-over from one or more of the following tests: · triglycerides, · triglycerides _2, · triglycerides concentrated, · cholesterol concentrated, and · direct ldl reagents. the carryover potential from these reagents is mitigated by setup of designated contamination avoidance protocols. however, in certain circumstances, rare incidences of carryover interference can occur.
  • 조치
    Siemens is actively investigating this situation in an effort to provide an improved contamination avoidance protocol for the Lipase assay to eliminate high-biased ADVIA Chemistry Systems Lipase assay results. Siemens has provided customers with a work around to mitigate this problem from occurring. This action has been closed-out on 01/03/2018.

Device

ADVIA Chemistry Systems Lipase Assay
  • 모델명 / 제조번호(시리얼번호)
    ADVIA Chemistry Systems Lipase AssayCatalogue Number: B01-4840-01, REF: 01984894Siemens Material Number: 10311896All lot number affectedARTG Number: 176331
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

Siemens Ltd Diagnostics Division