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

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.

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.