Events

Safety Alert for VIDAS ESTRADIOL II - ANVISA Register n ° 10158120172 - Lot: 8118666001. Reference: 30431

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by BIOMÉRIEUX 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
    883
  • Date
    2007-08-20
  • 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
    The company informs that until this date they have not received any complaints from the customers who purchased the product. It also informs that if the value of control C1 is outside the expected reading values, the results can not be validated. Anvisa will follow up on the case, in order to ensure that health products marketed in Brazil have the safety and efficacy necessary for the good performance of the product.
  • Reason
    Rfv reading (relative fluorescence value) of the kit's internal control (c1), outside of the acceptance criteria.
  • Action
    The company decided to block the commercialization of the lot and inform the customers of the collection of the lot involved.

Device

VIDAS ESTRADIOL II - ANVISA Register n ° 10158120172 - Lot: 8118666001. Reference: 30431

Manufacturer

BIOMÉRIEUX S.A.
  • Source
    ANVSANVISA