Events

Ortho Vision analyzer 의 안전성 경고

National Institute of Drugs and Food Surveillance (INVIMA)에 따르면, 해당 안전성 경고 는 Colombia 에서 Ortho Clinical Diagnostics || Tecan Schweiz Ag 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
    I1603-105
  • 사례 연번
    2015DM-0012864
  • 날짜
    2016-03-15
  • 사례 국가
    Colombia
  • 사례 출처
    INVIMA
  • 사례 출처 URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=151
  • 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 has detected an unlikely scenario in which a user improperly removes or exchanges the samples in a sample rack on board or removes a dilution tray on board after making the request to load / download reagents (reagents load / unload), if an inappropriate change is made in the site of the decarga station that was not selected through the user graphic interface (gui), the system will not detect the change, which could lead to the affectation of the results obtained in the processing of the samples.

Device

Ortho Vision analyzer
  • 모델명 / 제조번호(시리얼번호)
    6904578 and 6904579, serial 60002080, 60002096 and 60002277.
  • 제품 설명
    ORTHO VISION ANALYZER is a device designed to automate in vitro immunohematological analysis of human blood using ORTHOBIOVUE SYSTEM cassette technology. ORTHO VISION ANALYZER automates test processing functions, such as liquid pipetting, reagent handling, incubation, centrifugation, classification and interpretation of reactions and requirements for data management using cassettes and digital image processing. ORTHO VISION ANALYZER can be used as an independent device or connected to the customer's computer system (LIS).
  • Manufacturer
    Ortho Clinical Diagnostics || Tecan Schweiz Ag

Manufacturer

Ortho Clinical Diagnostics || Tecan Schweiz Ag