Events

Safety Alert for TROMBO ISI - ANVISA Record N ° 10158120102

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Biomerieux 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
    803
  • Date
    2005-04-14
  • 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
    Verify that you received the letter from Empresa Biomérieux Brasil SA, requesting the non-use of the product, until the collection of the table with the correct values. Identify and isolate any affected product in your inventory. For more information, contact your local representative or your own company by calling 0800264848. For further information, contact the ANVISA Technovigilance Unit, by e-mail tecnovigilancia@anvisa.gov.br or by telephone ( 61) 448-1485.
  • Reason
    Occurrence of error during transcription of inr value - for a time of 20.9 seconds and a reference time of 11.0 seconds, the inr is 3.85 and not 6.85.
  • Action
    The company decided to inform its customers immediately of not using the product, until the collection of the table with the correct values. Block the marketing of the product, and adjust the corrected table in the Blocked Kits.

Device

TROMBO ISI - ANVISA Record N ° 10158120102

Manufacturer

Biomerieux Brasil S.A
  • Source
    ANVSANVISA