ADVIA CENTAUR CP SYSTEM - CA 19-9 ASSAY 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
    21376
  • 사례 위험등급
    II
  • 사례 시작날짜
    2016-10-19
  • 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 diagnostic has observed a system to system bias between teh ca 19-9 assay on teh advia centaurj cp and advia centaur xp/avida centatur xpt systems with the advis centaur cp generating lower results than the advia centaur/advia centaur xp/advia centaur xpt system for patient samples. siemes is actively pursuing the cause of this issue.

Device

  • 모델명 / 제조번호(시리얼번호)
    Model Catalog: 10491244 (Lot serial: kits ending in 384); Model Catalog: 10491379 (Lot serial: kits ending in 380); Model Catalog: 10491244 (Lot serial: kits ending in 382); Model Catalog: 10491244 (Lot serial: kits ending in 380); Model Catalog: 10491379 (Lot serial: kits ending in 390); Model Catalog: 10491244 (Lot serial: kits ending in 390); Model Catalog: 10491379 (Lot serial: kits ending in 388); Model Catalog: 10491244 (Lot serial: kits ending in 388); Model Catalog: 10491379 (Lot serial: kits ending in 386); Model Catalog: 10491244 (Lot serial: kits ending in 386); Model Catalog: 10491379 (Lot serial: kits ending in 384); Model Catalog: 10491379 (Lot serial: kits ending in 382)
  • 제품 설명
    AVIDA Centaur CP system- CA 19-9 Assay;ADVIA Centaur system- CA19-9 Assay
  • Manufacturer

Manufacturer

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