Events

Safety Alert for ELISA CRUZI - Lot: 61207 - Reference 35117, Anvisa Registry # 10158120521 Contact the Owner

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Biomérieux Brasil 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
    863
  • Date
    2007-04-24
  • 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
    Due to the problem presented, considering that the batch involved, exhibits a profile outside the specifications and can compromise the routine of the customers, the Company decided to stop the commercialization, thus promoting the collection of the batch in question. If you have the listed lot in your inventory, contact your local representative or manufacturer by calling 0800.264848 - option 2. - Department of Scientific Support. ANVISA through the Technovigilance Unit will be following the case, in order to ensure that the health products marketed in Brazil have the safety and efficacy necessary to the good performance of the product. Update: On September 27, 2007, the Company presents the UTVIG, a copy of the certificate of destruction of the kits collected in the market.
  • Reason
    The reagent r3 of the batch in question is showing color change (orange to yellow), ph variation and false positive result.
  • Action
    Block the marketing, Inform the customers the collection of said lot

Device

ELISA CRUZI - Lot: 61207 - Reference 35117, Anvisa Registry # 10158120521 Contact the Owner

Manufacturer

Biomérieux Brasil S/A
  • Source
    ANVSANVISA