Alerta De Seguridad para MEDISENSE OPTIUM GLUCOSE STRIP TRUE MEASURE - Test Strips 10 Units Registration ANVISA nº10055311118

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por ABBOTT LABORATORIOS DO BRASIL LTDA.

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • ID del evento
    813
  • Fecha
    2005-08-10
  • País del evento
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
  • Notas / Alertas
    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.
  • Notas adicionales en la 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.
  • Causa
    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.
  • Acción
    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.

Manufacturer