Events

Safety Alert for VITEK 2 AST-YS 07. ANVISA Registration No. 10158120592.

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
    1552
  • Date
    2015-04-22
  • 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
    According to the risk assessment carried out by the company, the SEVERITY of the potential consequences for patients of incorrect or delayed results may be considered CRITICAL, which may lead to permanent deterioration, high impact on the patient's health or even death . The probability of occurrence was determined by the company as OCASIONAL, which means "possible to occur a few times during the product life cycle." The general risk posed by the company is MODERATED in a general way. relevant in Brazil since Flucitosycin is not used as therapy in case of fungemia (as it appears in the technical literature available in the market).
  • Reason
    During the quality control tests to be performed by the clients, it was identified that strain atcc 6258 - candida krusei, naturally resistant to the antibiotic flucitosina, presented results outside the minimum range required for such antibiotic, which means a sensitive result for flucitosina.
  • Action
    The company has already started communicating with its customers, alerting to the problem in question and is developing a new formulation for the product, which should be available within 6 months. Identify if you have products at risk in stock and carefully read the letter disclosed by the company, to take the necessary steps - letter available at http://portal.anvisa.gov.br/wps/wcm/connect/bae52680481c317688dfadbdc15bfe28/Notifica%C3 A + A + + + + + + + + + + + + + + + + + + + + + + + A9rieux.pdf • MOD = AJPERES)

Device

VITEK 2 AST-YS 07. ANVISA Registration No. 10158120592.

Manufacturer

Biomerieux Inc.