Events

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

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by ABBOTT LABORATORIES DIAGNOSTIC DIV.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    169
  • Date
    2000-10-27
  • Event Country
    Brazil
  • Event Source
    ANVISA
  • Event Source URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alerts
    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.
  • Extra notes in the data
    UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
  • Reason
    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 problems in manufacturing.
  • 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 PHONE1 (301) 827-1800.

Device

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

Manufacturer

ABBOTT LABORATORIES DIAGNOSTIC DIV
  • Source
    ANVSANVISA