Events

Alerta De Seguridad para Series 50 Supreme Blood Glucose Test Tapes. Lot #: 01031B, 12150B, 12220B, 12280B, 12290B; Part # 880050; NDC # 08317-8850-50; UPC # 0-15482-88005-7

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Hypoguard USA Inc A Medisys Group Co.

¿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
    399
  • Fecha
    2002-02-22
  • País del evento
    Brazil
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • 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
    UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
  • Causa
    The glucose test above may register a low inaccurate reading, which may cause the user to underestimate the glucose level. the manufacturer voluntarily initiated a correction by letter dated 4 january 2002.
  • Acción
    Make sure you received the letter dated January 4, 2002, mailing card, and Hypoguard customer notification letter. Identify and isolate any affected product in your inventory. Complete the customer's response card, and return by mail to Hypoguard. Using the notification letter, notify any of your customers who have received this product. If you have a product in your inventory, or for more information, contact your local Hypoguard representative. For further information, please contact ANVISA's Tecnovigilância Unit, by e-mail tecnovigilancia@anvisa.gov.br or by telephone (61) 448-1485.

Device

Series 50 Supreme Blood Glucose Test Tapes. Lot #: 01031B, 12150B, 12220B, 12280B, 12290B; Part #...

Manufacturer

Hypoguard USA Inc A Medisys Group Co
  • Source
    ANVSANVISA