Events

Safety Alert for KIT CHAGAS IGG ELISA - LOT 100.0112

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by MERIDIAN BIOSCIENCE. INC.

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
    94
  • Date
    2001-08-22
  • 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
    BRAZIL - OCTOBER 02, 2001 - REM INDUSTRIA E COMÉRCIO LTDA, INFORMES THAT THEY MARKED 677 KITS OF CHAGAS IGG ELISA FROM THE LOT OF 100.12, AND THAT ALL THE LOT WERE REPLACED.
  • Reason
    Increase in false-positive results associated with the lot tce 100,012.
  • Action
    THE COMPANY REM INDUSTRIA E COMÉRCIO LTDA DETENTORA DE REGISTRO DO PRODUCT IN BRAZIL ANNOUNCED ALL CUSTOMERS ON THE REPLACEMENT OF THE LOT TCE100.012 (PRODUCT NOTIFICATION)

Device

KIT CHAGAS IGG ELISA - LOT 100.0112

Manufacturer

MERIDIAN BIOSCIENCE. INC
  • Source
    ANVSANVISA