Events

Safety Alert for Trade Name: Glucose Technical Name: Glucose ANVISA Registration Number: 80046190076 Hazard Class: II Affected Model: Not applicable Serial Numbers Affected: Glucose BioSystems, code 11504; Affected Lot: 14560.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by EUROTECH PRODUTOS LABORATORIAIS E SERVIÇOS LTDA ME; BIOSYSTEMS 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
    2117
  • Date
    2016-11-08
  • 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
    It has been recommended to the end user that the product is not used.
  • Reason
    The manufacturer of the product glucose biosystems, code 11504; lot 14560 found that some units of the batch referenced did not contain glucose reagent but uric acid. based on the investigations, it was confirmed that the batch mentioned above has a labeling error.
  • Action
    Field Action Code triggered under the responsibility of the company EUROTECH LABORATORY PRODUCTS AND SERVICES LTDAME. Company will collect for later incineration.

Device

Trade Name: Glucose Technical Name: Glucose ANVISA Registration Number: 80046190076 Hazard Class:...

Manufacturer

EUROTECH PRODUTOS LABORATORIAIS E SERVIÇOS LTDA ME; BIOSYSTEMS SA
  • Source
    ANVSANVISA