Events

Alerta De Seguridad para CREATININE - R1 10x20ml + R2 2x25ml + Standard 1x3 ml; R1 1x 200ml + R2 1x50ml + Standard 1x3ml; R1 2x200ml + R2 1x100ml + Standard 1x3ml; R1 4x40mL + R2 4x10mL + 1x3mL Standard - ALL LOTS MANUFACTURED.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por KOVALENT 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
    1184
  • Fecha
    2012-09-25
  • 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
    There is a median probability of an incorrect creatinine value occurring in urine samples from patients with alkaptonuria (due to homogentisic acid). The severity and estimated risk is low if the test results are assured by the laboratory's internal quality control. The results of the tests should be checked critically by the health professional. Anvisa accompanies this Action. #### TERMINATION - 03/10/2012 - The company forwards Notice of Completion of the Field Action.
  • Causa
    High concentrations of hga in urine samples may interfere with photometric measurement with the enzymatic creatinine method and to a lesser extent with the jaffé method.
  • Acción
    The results of the tests must be ensured by the internal quality control of the laboratory. The results of the tests should be checked critically by the health professional. In addition, the health professional should evaluate the need for confirmatory tests, as well as take into consideration the patient's medical history and examination. In case of a discrepant result with the patient's clinic, confirm the result using a different method. Check the instruction for use of the product to evaluate information on possible interference.

Device

CREATININE - R1 10x20ml + R2 2x25ml + Standard 1x3 ml; R1 1x 200ml + R2 1x50ml + Standard 1x3ml; ...

Manufacturer

KOVALENT DO BRASIL LTDA