Events

Safety Alert for MEDISENSE OPTIUM GLUCOSE STRIP TRUE MEASURE - Test Strips 10 Units Registration ANVISA nº10055311118

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by ABBOTT LABORATORIOS DO BRASIL 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
    813
  • Date
    2005-08-10
  • 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
    This exchange, which signifies a disagreement with the date printed in the original box, occurred only in the first stage of adequacy, therefore both boxes with the correct validity and the incorrect validity were distributed on the market. The company Abbott Laboratories of Brazil, Diabetes Care Division, further clarifies that the Test Strips 10 Medisense Optium units are packaged individually, and in each strip there is printed information of the lot and the expiration date, which becomes visible at the correct date each use of the Test Strips. You still understand that this product will hardly be used after the correct expiration date (28/0212006), as it contains only 10 units. ANVISA will be accompanying the actions that will be carried out by the company.
  • Reason
    The product medisense optium - test strips with 10 units, lot 10422 with validity to 02/28/06, at the moment of adaptation, that is, in the labeling (which is done only to include the legal words - dealer's data in brazil, registration number, etc ...) there was an exchange of the product's expiration date. correct validity date: 02/28/06 - printed in the original box incorrect validity date: 06/28/06 - on the portuguese label.
  • Action
    The company issued a letter to its customers and is awaiting contact to know the impact of this occurrence on the stock and to meet the need to correct this operational failure. The company makes itself available for any clarification necessary through the Customer Service Center 0800 7030128 of Monday on Friday from 08:00 to 18:00 hours.

Device

MEDISENSE OPTIUM GLUCOSE STRIP TRUE MEASURE - Test Strips 10 Units Registration ANVISA nº10055311118

Manufacturer

ABBOTT LABORATORIOS DO BRASIL LTDA
  • Source
    ANVSANVISA