Events

Liquid Specific Protein (LSP) Calibrator 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-2014-RN-01204-1
  • 사례 위험등급
    Class III
  • 사례 시작날짜
    2014-11-13
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-01204-1
  • 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 has observed an increased frequency of max fit deviation flags using the lsp calibrator kit lot 303574 (vial lots 122it – 127it) to calibrate the alpha-1-antitrypsin (aat) assay. the max fit deviation flag impacts the level 2 calibrator (123it) for the advia chemistry systems alpha-1-antitrypsin (aat) assay. while there is a potential for delay in alpha-1-antitrypsin results due to calibration failures, the risk to health as a result of this issue is negligible.- the lsp calibrator ifu version that resided on the siemens document library from december 10, 2013 until april 7, 2014contained preliminary calibrator values that differed slightly from the final calibrator values for the following advia chemistry systems assays: aag, aat, aso_2, c3, c4, frt, hapt, iga_2, igg_2, igm_2, prealb, rf and trf. the differences between either the final or preliminary calibrator values would not affect the utility of these tests in clinical practice.
  • 조치
    Siemens is providing laboratories with the correct calibrator values.

Device

Liquid Specific Protein (LSP) Calibrator
  • 모델명 / 제조번호(시리얼번호)
    Liquid Specific Protein (LSP) CalibratorCatalogue Number: 07711199Lot Number: 303574Expiry Date: Nov 2015An in vitro diagnostic medical device (IVD)
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

Siemens Ltd Diagnostics Division