Events

LUMINEX Fluoroanalyzer 의 안전성 경고

National Institute of Drugs and Food Surveillance (INVIMA)에 따르면, 해당 안전성 경고 는 Colombia 에서 Luminex Corporation || Immucor Transplant Diagnostics, Inc 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
    R1704-142
  • 사례 연번
    2010DM-0006525
  • 날짜
    2017-04-25
  • 사례 국가
    Colombia
  • 사례 출처
    INVIMA
  • 사례 출처 URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=93
  • 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 informs that the client has reported problems since the month of the connectivity between the xponent 4.2 software and the medical device, which have been presented in a randomized manner, these problems are manifested with the error message "error getting device property" and subsequent blocking of the software, being necessary to restart the pc and analyzer to solve the inconvenience, leading to potentially delays in the processing of the samples and subsequent obtaining results.

Device

LUMINEX Fluoroanalyzer
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    The LUMINEX 200 system is designed for a wide range of laboratory test applications that measure biomolecular reactions on the surface of XMAP microspheres. This system is designed for the use of in-vitro diagnostics. The LUMINEX200 system is classified according to FDA 21 CFR 1040.10 and 1040.11 as a class II laser product consisting of a class I laser product (LUMINEX 200 analyzer) and a class II laser product (bar code reader).
  • Manufacturer
    Luminex Corporation || Immucor Transplant Diagnostics, Inc

Manufacturer

Luminex Corporation || Immucor Transplant Diagnostics, Inc
  • Source
    NIDFSINVIMA