Events

HER2 CISH pharm dx 의 안전성 경고

National Institute of Drugs and Food Surveillance (INVIMA)에 따르면, 해당 안전성 경고 는 Colombia 에서 DAKO || Importer: ROCHEM BIOCARE 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
    RRD-090616
  • 사례 연번
    INVIMA 2013RD-0002654
  • 날짜
    2016-06-29
  • 사례 국가
    Colombia
  • 사례 출처
    INVIMA
  • 사례 출처 URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=134
  • 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
    Low concentrations of reagent contained in vial 3 during batch production. as a result, the concentration of the her2 test is too low, causing reduction of the quality of the coloration, according to the variability of the tissues. when her2 cish pharmdx kit, code sk109 is used in accordance with the instructions for use, blue and red discolorations are easily visible in the normal cells of the tissue sample. if these control signals are not identified in the normal cells, the results of the tests may not be conclusive for the affected flock. the inability to clearly identify such red and blue signals in normal cells indicates a failure of the evaluation and the test should be repeated with a new batch. this may cause a potential delay in diagnosis. however, if the control signals are not checked according to the instructions for use, there is a risk of erroneous diagnosis due to a false negative result.

Device

HER2 CISH pharm dx

Manufacturer

DAKO || Importer: ROCHEM BIOCARE COLOMBIA S.A.S