Alerta De Seguridad para IChem® VELOCITY Urine Strips; lot: 7204051B; Registration: 80012590204

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por TOF Comercial Ltda.; IRIS Diagnostics.

¿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
  • Fecha
  • País del evento
  • Fuente del evento
  • 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
    The company reports that false negative nitrite results may lead to an error in the etiology of Urinary Tract Infection (UTI). The problem would lead to a misunderstanding in the initial results of the urinalysis, with delay in obtaining the correct diagnosis between 12-24 hours and, in the worst cases, 24-48 hours (time taken to obtain the final results of the urine culture and tests of sensitivity). In the latter case, if there is an unrecognized UTI infection by Proteus that is resistant to conventional treatments, considered inadequate and / or inappropriate, the patient's condition may progress from worsening UTI to prioelonephritis, from pyelonephritis to sepsis, septic shock , stone formation in the kidney, renal failure and renal abscess formation. In diabetic and immunosuppressed / HIV patients, there is also the risk of emphysematous pyelonephritis, with the introduction of air in the kidneys resulting in permanent damage to the kidney in case of recovery. In pregnancy, there is also fetal risk or death./// Update on 05/26/2014 - The company informed that the collection action was completed and that all customers contacted informed that they did not have the product in stock.
  • Causa
    A portion of the ichem velocity urine chemical strips from lot 7204051b (bottles number 16113 to 17000) was fabricated with an incorrect nitrite reaction area, which could generate false-negative nitrite results. of a total of 6,688 bottles manufactured from this batch, after investigation of the manufacturer it was detected that only 887 fr. (13.4%) presented the problem.
  • Acción
    The company directs: • Inspect all remaining units in stock from Lot 7204051B to check if it has bottles numbered 16113 through 17000. • Discontinue use of the affected bottles and dispose of all remaining product in accordance with the procedures. • Replace the product with customers. • To the laboratories that used the affected flasks, reassess the samples previously tested. • Patients with signs and symptoms of Urinary Tract Infection (UTI) who have any of the test results below and negative nitrite results should repeat the test with another batch of strips: i) Urinary Chemistry: Positive Leucocyte Esterase, Negative Nitrite; ii) Urinary Microscopy: White Blood Cells Positive, Negative Nitrite. For more information, check the attachments I - Customer Letter and II - Distribution Map or contact the company by email: