ADVIA CHEMISTRY SYSTEM - TRIGLYCERIDES_2 CONCENTRATED REAGENTS (TRIG_C) 의 리콜

Health Canada (via FOI)에 따르면, 해당 리콜 는 Canada 에서 SIEMENS HEALTHCARE LIMITED 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
    142712
  • 사례 위험등급
    III
  • 사례 시작날짜
    2016-03-09
  • 사례 국가
  • 사례 출처
    HC
  • 비고 / 경고
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • 데이터 추가 비고
  • 원인
    Siemens healthcare diagnostics has confirmed the advia chemistry triglyceride concentrated reagent (trig_c) does not meet instructions for use (ifu) linearity claim at the upper limit of the assay range as it approaches end of shelf life for lots 348297 and 359932. internal testing demonstrated that a patient bias (-12% to -15%) may be seen at concentration levels between 450 to 550mg/dl (5.085 - 6.215mmol/l). linearity is reduced by approximately 30% at higher triglyceride concentrations up to 1200mg/dl (13.56mmol/l). quality control (qc) material may not detect this issue depending on the concentrations used during qc testing.

Device

  • 모델명 / 제조번호(시리얼번호)
    Model Catalog: 10697575 (Lot serial: 348297); Model Catalog: 10697575 (Lot serial: 359932)
  • 제품 설명
    ADVIA CHEMISTRY - TRIGLYCERIDES_2 CONCENTRATED REAGENTS (TRIG_C)
  • Manufacturer

Manufacturer

  • 제조사 주소
    OAKVILLE
  • 제조사 모회사 (2017)
  • Source
    HC