Events

Clinitek uroanalysis analyzer 의 안전성 경고

National Institute of Drugs and Food Surveillance (INVIMA)에 따르면, 해당 안전성 경고 는 Colombia 에서 Siemens Health Care Diagnostics Inc || Siemens Health Care Diagnostics Manufacturing Limited 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

안전성 경고는 의료기기 제품과 관련된 중요한 정보와 권고사항을 담고 있습니다. 물론 안전성 경고가 배포되었다고 해서 해당 제품이 무조건 안전하지 않은 제품이라는 것은 아닙니다. 보건의료업계 종사자와 의료기기 사용자들에게 배포되는 안전성 경고에는 회수(recall)도 포함될 수 있습니다. 제조사가 안전성 경고를 작성하기도 하지만, 보건당국에서 작성하는 경우도 있습니다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Safety alert
  • 사례 ID
    I1508-355
  • 사례 연번
    2014DM-0011303
  • 날짜
    2015-08-03
  • 사례 국가
    Colombia
  • 사례 출처
    INVIMA
  • 사례 출처 URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=174
  • 비고 / 경고
    Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 Colombia.
  • 데이터 추가 비고
  • 원인
    The manufacturer states that it has identified a potential error in the reports obtained with the referenced analyzer, if the clarity report adjustment is disabled, leading to potential failures in the analysis of samples and subsequent diagnosis.

Device

Clinitek uroanalysis analyzer
  • 모델명 / 제조번호(시리얼번호)
    NOVUS WITH RACK, serial S001046, S001259, S001294, S001295, S001308, S001331, S001333, S001524, S001555, || S001311, S001312, S001313, S001328, S001520, S001550, || S001553 and S001569
  • 제품 설명
    The CLINITEK NOVUS ™ automatic urine chemical analyzer is a fully automated urine analyzer. It is designed for professional use in vitro diagnosis. The CLINITEK NOVUS analyzer is designed to read only SIEMENSHEALTHCARE DIAGNOSTICS CLINITEK NOVUS cassettes. Elanalizer is designed to measure the following components of urine: albumin, bilirubin, blood (occult), creatinine, glucose, ketone (acetoacetic acid), leukocytes, nitrite, ph, proteins, urobilinogen, density (specific gravity), albumin-creatinine ratio and protein-creatinine ratio. These measures are used to help make the diagnosis in the following areas: carbohydrate metabolism (such as diabetes mellitus), kidney function, liver function, metabolic disorders, urinary tract infections the analyzer reports the color and appearance of the sample. The automatic urine analyzerCLINITEK NOVUS is designed for centralized laboratories.
  • Manufacturer
    Siemens Health Care Diagnostics Inc || Siemens Health Care Diagnostics Manufacturing Limited

Manufacturer

Siemens Health Care Diagnostics Inc || Siemens Health Care Diagnostics Manufacturing Limited