Events

Safety Alert for Vitek 2 GN Cards - Identification of gram negatives.

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
    1416
  • Date
    2014-08-26
  • 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
    Fill out and send the Kis Recall Notification form for withdrawal and replacement of the product. Access Security Card at: http://portal.anvisa.gov.br/wps/wcm/connect/b2e1558045699635840fc4e23d5c835b/Carta+Seguran%C3%A7a_Biomerieux.pdf?MOD=AJPERES
  • Reason
    A nonconformity was detected on the vitek 2 gn - identification card for gram negative, when some escherichia coli isolates were tested. it was determined that for the aglu substrate, some false positives may occur for some strains of escherichia coll, causing an incorrect identification of e. coli isolates, such as serratia fonticola.
  • Action
    Ensure that the guidance letter has been dis- tributed and reviewed for all appropriate personnel within the organization. Analyze your current inventory of caths 2 Negative Gram Identification. If you still have Kits of the affected product (Ref. 21341, Lot 241289140), discontinue use of the same and contact the Customer Service of Biomerieux for collection and replacement of the product.

Device

Vitek 2 GN Cards - Identification of gram negatives.

Manufacturer

Biomerieux Inc.