INSTRUMENT MANAGER 의 리콜

Health Canada (via FOI)에 따르면, 해당 리콜 는 Canada 에서 DATA INNOVATIONS LLC 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
    86169
  • 사례 위험등급
    II
  • 사례 시작날짜
    2013-11-05
  • 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
    When results of "---.-" are received from the sysmex uf-100 instrument and if the user set the driver configuration option "strip zeros from result" to "yes" all versions prior to v7.00.0006 and v8.00.0005 of the sysu100i driver convert the results to "0.00" in instrument manager. the sysmex uf-100 will send "--.-" when the test has a sample error. all five urinalysis tests performed (rbc wbc ec cast and bact) will be resulted as "0.00" in instrument manager. this could lead to misdiagnosis and mistreatment of a patient.

Device

  • 모델명 / 제조번호(시리얼번호)
    Model Catalog: 8.00.0003 (Lot serial: Not applicable); Model Catalog: 8.00.0002 (Lot serial: Not applicable); Model Catalog: 8.00.0004 (Lot serial: Not applicable); Model Catalog: 7.00.0001 (Lot serial: Not applicable); Model Catalog: 7.00.0002 (Lot serial: Not applicable); Model Catalog: 7.00.0003 (Lot serial: Not applicable); Model Catalog: 7.00.0005 (Lot serial: Not applicable); Model Catalog: 8.00.0001 (Lot serial: Not applicable); Model Catalog: 7.00.0004 (Lot serial: Not applicable)
  • 제품 설명
    Instrument Manager Software using the sysu100i driver that connects to the Sysmex UF-100 instrument
  • Manufacturer

Manufacturer