Events

ABBOTT / MUREX DISCHARGEABLE TESTS OF HUMAN IMMUNODEFICIENCY DIAGNOSTIC SYSTEMS VIRUS 1 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 ABBOTT LABORATORIES DIAGNOSTIC DIV 에 의해 제조된 제품과 관련되어 있습니다.

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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
    168
  • 날짜
    2000-10-27
  • 사례 국가
    Brazil
  • 사례 출처
    ANVISA
  • 사례 출처 URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • 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
    UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
  • 원인
    Fda reports about an abbott diagnostics letter sent on october 8, 2000, where abbott diagnostics informs users that the suds hiv-1 test, the only us approved hiv test, will not be available for any indeceured period, in reason for manufacturing problems.
  • 조치
    The FDA RECOMMENDS THE FOLLOWING PROVISIONAL MEASURES THAT MAY BE ADOPTED BY HEALTH CARE PROFESSIONALS: (1) IMMEDIATE TESTS WITH ENZYMAL IMMUNOSENSES (EIA) CURRENTLY APPROVED. The FDA DECLARES THAT THIS TEST METHOD CAN STANDARDLY BE MADE BETWEEN 90 AND 160 MIN. (2) TESTS WITH THE HEALTHY CHEMIA FLUOROGNOST HIV-1 INDIRECT TEST WITH IMMUNOFLUORESCENCE (IFA), APPROVED FOR USE AS AN HIV SCREENING TEST WHEN THE EIA TEST IS NOT PRACTICAL. THE TEST CAN BE DONE IN APPROXIMATELY 100 MIN. The FDA DECLARES THAT SOMETHING OF EMERGENCY MEDICAL DECISIONS MAY BE BASED ON THE RESULTS OF HIV TRIALS, REACTIVE TRIAL TESTS MUST BE CONFIRMED THROUGH COMPLEMENTARY TESTS, SUCH AS THE IFA OR THE WESTERN BLOT. The FDA RECOMMENDS THAT HEALTH PROFESSIONALS IMPLEMENT ONE OF THE PROVISIONAL MEASURES SUGGESTED TO REPLACE THE SUDS HIV-1 TEST. FOR FURTHER INFORMATION, CONTACT YOUR LOCAL ABBOTT REPRESENTATIVE OR DIRECTLY WITH THE BIOLOGICAL EVALUATION AND CONSUMER AFFAIRS OFFICE OF THE CENTER FOR BIOLOGICAL EVALUATION AND RESEARCH'S CONSUMER AFFAIRS BRANCH, OFFICE OF COMMUNICATION, TRAINING AND MANUFACTURER ASSISTANCE), BY TELEPHONE1 (301) 827-1800

Device

ABBOTT / MUREX DISCHARGEABLE TESTS OF HUMAN IMMUNODEFICIENCY DIAGNOSTIC SYSTEMS VIRUS 1

Manufacturer

ABBOTT LABORATORIES DIAGNOSTIC DIV
  • Source
    ANVSANVISA