Events

Safety Alert for Technopath Multichem IA Plus, registration: 80146501893, Class of Risk: III - high risk product to individual and / or medium to public health, serial number / lot: 33505140.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by ABBOTT LABORATÓRIOS DO BRASIL LTDA.; TECHNO-PATH MANUFACTURING 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
    1560
  • Date
    2015-04-02
  • 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
    The stability specifications of the opened bottle in the Instructions for Use written in Portuguese do not apply to lot 33505140.
  • Reason
    02 problems were recorded: incorrect instruction resulting in an error in the stability specifications of the open bottle; the process of suitability was carried out outside the appropriate temperature conditions, i.E. at a temperature of -20 ° c or below. the consequence of subjecting the product to a partial freeze-thaw cycle is the change in its performance.
  • Action
    The registration holder advises customers to discontinue use of the product in accordance with laboratory procedures and forward letter to the company to arrange for the product to be collected.

Device

Technopath Multichem IA Plus, registration: 80146501893, Class of Risk: III - high risk product t...

Manufacturer

ABBOTT LABORATÓRIOS DO BRASIL LTDA.; TECHNO-PATH MANUFACTURING LTDA.
  • Source
    ANVSANVISA