Events

Film Array Blood Culture Identification BCID Panel 의 안전성 경고

National Institute of Drugs and Food Surveillance (INVIMA)에 따르면, 해당 안전성 경고 는 Colombia 에서 BIOFIRE DIAGNOSTICS LLC || Importer: BIOMERIEUX COLOMBIA S.A.S. 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
    IRD-030516
  • 사례 연번
    INVIMA 2014RD-0003003
  • 날짜
    2016-05-03
  • 사례 국가
    Colombia
  • 사례 출처
    INVIMA
  • 사례 출처 URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=143
  • 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
    Labeling problem with a suitable electronic code key, generating the download of an obsolete version of the instructions of the product by the customers. the obsolete use instructions refer to the old syringe loading system, in contrast to the current system, which is based on an injectable method of the vial. the most significant difference between the two sets of instructions is the volume of the sample needed to perform the test. the syringe system requires 100 ul of the sample, while the new system requires 200 ul demonstrates. biofire has shown that there are no differences between the two sample volumes, therefore, any risk to patients and the risk of erroneous results are very low.

Device

Film Array Blood Culture Identification BCID Panel
  • 모델명 / 제조번호(시리얼번호)
    Code: RFIT-ASY-0126, lots 440415, 442715, 447415, 447615, || 448315, 454115, 458915, 459615, 462615, 470515, 400216, || 400716, 403016, 403616, 405416, 407016, 407416, 410216, || 412516. || Code: RFIT-ASY-0127, lots: 438115, 449515, 442815, 459715, || 463115, 468015, 410016
  • 제품 설명
    DETERMINATION OF DIFFERENT ANALYTICS RELATED TO SAMPLES FROM THE HUMAN ORGANIZATION
  • Manufacturer
    BIOFIRE DIAGNOSTICS LLC || Importer: BIOMERIEUX COLOMBIA S.A.S.

Manufacturer

BIOFIRE DIAGNOSTICS LLC || Importer: BIOMERIEUX COLOMBIA S.A.S.