Events

Alerta De Seguridad para CREATININE FLEX® REAGENTS CARTRIDGE (CREA)

Según National Institute of Drugs and Food Surveillance (INVIMA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Colombia que fue producido por SIEMENS HEALTHCARE DIAGNOSTICS / SIEMENS || HEALTHCARE COLOMBIA.

¿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
    IRD-010716
  • Número del evento
    INVIMA 2006RD-0000116
  • Fecha
    2016-07-01
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=134
  • Notas / Alertas
    Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 recall data from the U.S. and Colombia.
  • Notas adicionales en la data
  • Causa
    Negative bias, causing low results in the range of analytical (amr) urine. this drawback results in the impossibility of reaching the required quantification limit (5 mg / dl [442 mg / dl]) for urine samples. however, the observed bias for urine samples at creatinine concentrations below 13 mg / dl has no impact on the clinical interpretation of the calculation of the glomerular filtration rate or on the clinical interpretation of laboratory tests using creatinine as a correction factor in the calculation of albumin and proteins in urine.

Device

CREATININE FLEX® REAGENTS CARTRIDGE (CREA)
  • Modelo / Serial
    CATALOG DF33B, CODE SMN10872079, All batches and || future lots || CATALOG K1033A CODE SMN 10872082 All batches and || future lots
  • Descripción del producto
    THESE 15 PRODUCTS ARE USED TO MAKE TESTS OF BLOODY CHEMISTRY OF SAMPLES PROPOSED BY THE HUMAN BODY.
  • Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS / SIEMENS || HEALTHCARE COLOMBIA

Manufacturer

SIEMENS HEALTHCARE DIAGNOSTICS / SIEMENS || HEALTHCARE COLOMBIA
  • Empresa matriz del fabricante (2017)
    Siemens Ag
  • Source
    NIDFSINVIMA