Events

Safety Alert for ACCESS FOLATE CALIBRATORS - Record 10033120535 - Affected batches 112788, 122651 and 123635.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by BECKMAN COULTER DO BRASIL COM. E IMP. DE PRODUTOS DE LABORATÓRIO LTDA..

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
    1175
  • Date
    2012-09-10
  • 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
    Anvisa is following this field action. At the moment there is no record of notifications in the NOTIVISA System.
  • Reason
    Loss of stability before the declared date, with consequently falsely high result.
  • Action
    Immediately stop using the affected product; verify the existence of the same in your inventory, segregate and communicate your supplier for recall and replacement.

Device

ACCESS FOLATE CALIBRATORS - Record 10033120535 - Affected batches 112788, 122651 and 123635.

Manufacturer

BECKMAN COULTER DO BRASIL COM. E IMP. DE PRODUTOS DE LABORATÓRIO LTDA.