ADVIA CENTAUR CP SYSTEM - CA 125II 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
    126636
  • 사례 위험등급
    III
  • 사례 시작날짜
    2018-02-23
  • 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 is issuing a communication to advise that some patient samples exhibit sample specific dilution over-recovery outside of the representative dilution recovery data provided in the advia centaur ca 125ii assay instruction for use. investigations performed by siemens healthcare diagnostics demonstrated dilution recoveries up to 140% with certain patient samples. studies indicate the dilution over-recovery is patient sample specific. the advia centaur ca 125ii assay instruction for use will be updated to include a statement refering to the potential for sample specific non-linear dilution. the performance of the advia centaur ca 125ii assay has not changed.

Device

  • 모델명 / 제조번호(시리얼번호)
    Model Catalog: 01678114 (Lot serial: >100 numbers contact mfg); Model Catalog: 09427226 (Lot serial: >100 numbers contact mfg)
  • 제품 설명
    ADVIA CENTAUR CP SYSTEM - CA 125II ASSAY;ADVIA CENTAUR SYSTEM - CA 125 II ASSAY
  • Manufacturer

Manufacturer

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