Events

Alerta De Seguridad para Alanine Aminotransferase (ALT) Glucose-STAT

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 BECKMAN COULTER INC || Importer:ROCHEM BIOCARE COLOMBIA S.A.

¿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-020616
  • Número del evento
    INVIMA 2006RD-0000208
  • Fecha
    2016-06-08
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=137
  • 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
    Low results in patients treated with sulfasalazine and sulfapyridine. the interference observed at concentrations of 300 mg / l of sulfasalazine showed a negative bias of up to 35% for the low control of alt and up to 29% for the high control of alt. the interference observed with a concentration of 300 mg / l of sulfasalazine showed a 10% sga up to 25% (or 1.3 mmol / l) for the control of the glucose - stat low and up to 13% (or 1.6 mmol / l ) for the control of glucose - stat. at concentrations of 300 mg / l of sulfapyridine, a positive bias of up to 21% (or 1.1 mmol / l) was demonstrated for glucose control- low stat and up to 9% or (1.1 mmol / l) for glucose control - high stat.

Device

Alanine Aminotransferase (ALT) Glucose-STAT
  • Modelo / Serial
    ALANIN AMINOTRANSFERASE (ALT), reference OSR6X07, all batches. GLUCOSE-STAT, reference OSR6X40, all batches.
  • Descripción del producto
    QUANTITATIVE DETERMINATION OF RELATED ANALYTS, IN SAMPLES FROM THE HUMAN MOTION.
  • Manufacturer
    BECKMAN COULTER INC || Importer:ROCHEM BIOCARE COLOMBIA S.A

Manufacturer

BECKMAN COULTER INC || Importer:ROCHEM BIOCARE COLOMBIA S.A