Events

Safety Alert for AGAR CLED MEDIUM, Brand: Biomerieux, Record: 101581120601, lot 1411111100 valid for 3/27/2015.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Biomerieux Brasil SA..

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
    1539
  • Date
    2015-03-16
  • 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 company the contamination is visible to the customer and advises not to use the plate when non-compliance.
  • Reason
    The company holding the record identified late contamination of the stock stock.
  • Action
    It is guided by the manufacturer company that the plates of the affected lot are returned. In case of impossibility of return the orientation is discarded.

Device

AGAR CLED MEDIUM, Brand: Biomerieux, Record: 101581120601, lot 1411111100 valid for 3/27/2015.

Manufacturer

Biomerieux Brasil SA.