Events

Alerta De Seguridad para ABBOTT / MUREX DISCHARGEABLE TESTS OF HUMAN IMMUNODEFICIENCY DIAGNOSTIC SYSTEMS VIRUS 1

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por ABBOTT LABORATORIES DIAGNOSTIC DIV.

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • ID del evento
    168
  • Fecha
    2000-10-27
  • País del evento
    Brazil
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
  • Causa
    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.
  • Acción
    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