TREPANOSTIKA TP RECOMBINANT - Registration ANVISA nº 10158120502, Reference 285034 - Lots D37FA and D37FB, Reference 285035 - Lots D37FA and D37FB - Validity: 06/2007, 07/2007 and 08/2007 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 BIOMÉRIEUX BV 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
    852
  • 날짜
    2007-01-10
  • 사례 국가
  • 사례 출처
    ANVISA
  • 사례 출처 URL
  • 비고 / 경고
    Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 data from the U.S. and Brazil.
  • 데이터 추가 비고
    The Company informs that after risk assessment, it reiterates that there is no sanitary impact, since in case of occurrence of the problem, the race is given with invalid. He also states that there was no question from the customers who purchased the product. For further clarification, please contact your local representative or the customer service department - Biomérieux 0800264848. The Company, through a file sent to UTVIG dated March 16, 2007, informs the closing of the collection.
  • 원인
    There is an increased risk that the absorbance of the negative control, whether very high - negative control is not within the qualification values, as described in the instructions for use.
  • 조치
    The company informs that it is taking all steps to solve the problem and decided: 1 - Block the commercialization of the lots, 2 - Inform its clients the collection of lots by means of notification (letter).

Manufacturer

  • Source
    ANVSANVISA