DIMENSION CHEMISTRY WASH 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
    63778
  • 사례 위험등급
    II
  • 사례 시작날짜
    2013-05-17
  • 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 received complaints of chemistry wash causing qc and patient sample result shifts on ctni ltni ft4 tsh pbnp and lpbn when using chemistry wash lots rd23031 rd23111 rd23241 rd23311 rd23391 and rd23461. these lots shipped between 12/12/2012 and 3/22/2013. internal investigation has confirmed shifts can be encountered in two scenarios: 1. when an affected lot of chemistry wash is placed on the instrument following an unaffected lot a negative bias will be seen on ctni ltni tsh pbnp and lpbn. a positive bias will be seen on ft4. 2. if any of these assays are calibrated using an affected lot of chemistry wash qc should return within range but when a subsequent unaffected chemistry wash lot is placed into use a positive bias will be seen on ctni ltni tsh pbnp and lpbn. a negative bias will be seen on ft4.

Device

  • 모델명 / 제조번호(시리얼번호)
    Model Catalog: 10445052 (Lot serial: RD23031); Model Catalog: 10445052 (Lot serial: RD23111); Model Catalog: RD701 (Lot serial: RD23241); Model Catalog: 10445052 (Lot serial: RD23241); Model Catalog: RD701 (Lot serial: RD23311); Model Catalog: RD701 (Lot serial: RD23031); Model Catalog: RD701 (Lot serial: RD23391); Model Catalog: 10445052 (Lot serial: RD23391); Model Catalog: RD701 (Lot serial: RD23461); Model Catalog: 10445052 (Lot serial: RD23461); Model Catalog: RD701 (Lot serial: RD23111); Model Catalog: 10445052 (Lot serial: RD23311)
  • 제품 설명
    DIMENSION CHEMISTRY WASH
  • Manufacturer

Manufacturer

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