Events

Safety Alert for SLIDEX MENINGITE KIT 5 - ANVISA Registration nº 10158120198, Expiration of Registration: 19/12/2011, LOT NO .: 804114501, valid for lot: 12/21/2006.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Biomérieux Brasil S/A.

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
    843
  • Date
    2006-11-27
  • 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
    According to company information following the investigations and risk analysis, they concluded that the health impact is extremely low, as the etiological diagnosis of bacterial meningitis is based on a set of diagnostic tests and clinical evaluation. The symptoms are usually accompanied by antibiotic therapy. The Unit of Technovigilance - UTVIG / NUVIG / ANVISA is monitoring the actions of the company. ////////// In a letter dated December 20, 2006, the Company informs the closure of voluntary collection.
  • Reason
    Reports, 04 complaints, being 01 in brazil, of loss of sensitivity gradient of reagent r5 (antimenigiccic type c) against r6 (positive control), and eventual release of false negative results may occur.
  • Action
    The company informs the blocking and the commercialization of the lot, and communicates to its customers by means of collection letter of the lot 804114501.

Device

SLIDEX MENINGITE KIT 5 - ANVISA Registration nº 10158120198, Expiration of Registration: 19/12/20...

Manufacturer

Biomérieux Brasil S/A
  • Source
    ANVSANVISA