Events

urine analyzer 의 안전성 경고

National Institute of Drugs and Food Surveillance (INVIMA)에 따르면, 해당 안전성 경고 는 Colombia 에서 N/A 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 연번
    2014DM-0011237 ; 2014DM-0011773
  • 날짜
    2018-02-07
  • 사례 국가
    Colombia
  • 사례 출처
    INVIMA
  • 사례 출처 URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=56
  • 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

Device

urine analyzer
  • 모델명 / 제조번호(시리얼번호)
    u601 and u701, specific serials.
  • 제품 설명
    The urine analyzer cobas u 601 (called the urine analyzer in a generic way) is a fully automated urinalysis system designed for the qualitative quantitative in vitro quantitative determination of urinary analytes, such as PH, leukocytes, nitrites, proteins, glucose, ketones, urobilinogen, bilirubin yerithrocytes, as well as specific density, color and turbidity. These measurements are useful in the evaluation of renal, urinary, hepatic and metabolic disorders. This system is intended to be used by qualified operators in clinical laboratories. The analyzer can process up to 240 samples per hour. It is automated.The team cobas u 701 MICROSCOPY ANALYZER (denominadomicroscopio analyzer) is an orinatotalmente automated microscopy system designed for the quantitative invitro determination of erythrocytes and leukocytes, for the semiquantitative determination of squamous and non-squamous epithelial cells, bacteria and cylindershyaline and for the qualitative determination of pathological cylinders, crystals, yeast, mucus and sperm in the urine. The instrument consists of a microscopy system which increases the urinary sediment of the patients sample and presents them on an LCD screen for reading and review by the laboratory professional. These measurements are useful in the evaluation of renal, urinary, hepatic and metabolic disorders. This system is intended to be used by operators qualified in clinical laboratories.
  • Manufacturer
    N/A

Manufacturer

N/A
  • Source
    NIDFSINVIMA