Events

Safety Alert for Automatic histology slide dye applicator

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Ventana Medical Systems 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
    216
  • Date
    2000-12-01
  • 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
    UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
  • Reason
    The dispensers mentioned may leak through the air inlet on the cover, the interface of the cover and the cannon, or the nozzle. the manufacturer initiated a mail-order withdrawal sent on june 30, 2000. the company did not provide any information to ecri.
  • Action
    Make sure you have received the correspondence sent on June 30, 2000 by Ventana Medical Systems. Identify and collect any affected product from your inventory. For more information, contact your local representative or directly with Ventana Medical Systems at 1 (520) 887-2155 in the United States.

Device

Automatic histology slide dye applicator

Manufacturer

Ventana Medical Systems Inc
  • Source
    ANVSANVISA