Events

Safety Alert for Product name: VITEK AST N 239 Card - Colistin (cs01n) Technical Name: VITEK AST Card N 239 ANVISA Registration Number: 10158120592 Hazard Class: II Model Affected: Not Applicable

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by bioMérieux Brasil Ind. Com. de Prod. Lab. ltda.; bioMérieux 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
    2300
  • Date
    2017-05-24
  • 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
    For the reasons explained in the brief description of the problem, we recommend to customers (users of the Vitek AST N 239 card): 1- Use an alternative method (which they must decide which to implement, based on the technical literature available in the microbiology area), before colitis, when using the Vitek 2AST N 239 card (cs01n). 2 - Create the BIOART rule in Vitek equipment, to stop the emission of the results for colistin until the supporting test (optional method mentioned above) is completed (Vitek 2 Reference Manual Software Online). 3- Ensure that the guidelines contained in the letter to the clients (attached to this form) will be passed on to all appropriate personnel in their laboratories for their science. 4- Keep the guidance letter filed with the technical documentation of the Vitek 2 equipment. 5- Complete the knowledge form that accompanies the letter to the clients and return the same as soon as possible to the Dept. of Integrated Customer Service for bioMérieux Brasil.
  • Reason
    Eucast and clsi have issued a recommendation that the broth microdilution method is the only method for antibiotic susceptibility testing recommended for the antibiotic colistin. as a result some customers contacted biomérieux with issues related to the vitek 2ast n 239 card (cs01n), as this product was developed by dilution in agar. an investigation was developed to document the performance level of the vitek 2ast n 239 card (cs01n) and to identify any possibility of deviation of this card from its development. the investigative tests included the card in question and broth microdilution and microdilution agar methods; using 290 isolates with varying degrees of colistin sensitivity. two control microorganisms were included in the test (e.Coli atcc 25922 and p.Aeruginosa atcc 27853). the mic results for the 03 methods were purchased and evaluated. the research demonstrated an unacceptable level of false susceptibility with vitek 2ast n 239 (cs01n) when compared to agar dilution (reference method employed in carton development) and broth microdilution (eucast and clsi recommended method) ). in recent years the use of colistin has been greatly increased, giving rise to a change in epidemiology since the development of vitek 2ast n 239 (cs01n). internal investigations concluded that the carton in question for colistin did not perform adequately when compared to broth microdilution and agar dilution methods.
  • Action
    Field Action Code FSCA 3490 triggered under the responsibility of the company bioMérieux Brasil Indústria e Comércio de Produtos Laboratoriais Ltda. Company will advise clients on the use of optional methodology for "susceptible" results related to the antibiotic Colistina cs01n, contained in Vitek AST N 239.

Device

Product name: VITEK AST N 239 Card - Colistin (cs01n) Technical Name: VITEK AST Card N 239 ANVISA...

Manufacturer

bioMérieux Brasil Ind. Com. de Prod. Lab. ltda.; bioMérieux Inc.