Events

Safety Alert for VITEK 2 XL and VITEK 2 COMPACT (Anvisa Record: 10158120549).

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by BIOMERIEUX 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
    907
  • Date
    1111-11-11
  • 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
    If necessary, customers should use the telephone 0800-26-4848 or the email contato@sa.biomerieux.com to get in touch with Biomerieux Brasil SA. Anvisa's Technovigilance Unit is monitoring this case.
  • Reason
    The manufacturer company verified that some strains of the acinetobacter baumannii microorganism present "sensitive" final results for the susceptibility test carried out on the vitek 2 xl and vitek 2 compact systems, against the antibiotic amicacin; in the presence of reference methods, such strains present "resistant" final results.
  • Action
    The company Biomerieux Brasil SA has informed that it has sent letters of communication to the clients involved, instructing the users of the cited products to carry out alternative methodology before releasing the result (s) of susceptibility test (s) antibiotic / antigen ratio Amicacin x Acinetobacter baumannii.

Device

VITEK 2 XL and VITEK 2 COMPACT (Anvisa Record: 10158120549).

Manufacturer

BIOMERIEUX INC
  • Source
    ANVSANVISA