Events

Alerte De Sécurité sur ABBOTT / MUREX DISCHARGEABLE TESTS OF HUMAN IMMUNODEFICIENCY DIAGNOSTIC SYSTEMS VIRUS 1

Selon Agência Nacional de Vigilância Sanitária (ANVISA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Brazil qui a été fabriqué par ABBOTT LABORATORIES DIAGNOSTIC DIV.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • ID de l'événement
    168
  • Date
    2000-10-27
  • Pays de l'événement
    Brazil
  • Source de l'événement
    ANVISA
  • URL de la source de l'événement
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
  • Cause
    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.
  • Action
    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