Events

Alerta De Seguridad para Access Free T3

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. || Imported by: ROCHEM BIOCARE COLOMBIA S.A./ || ANÁLISIS TÉCNICOS 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
    IRD-030616
  • Número del evento
    INVIMA 2006RD-0000208
  • Fecha
    2016-06-20
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=135
  • 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
    Positive displacement in the patient's results. the preliminary results indicate that this increase in the results may be related to a change in the reagent formulation in june 2015, which was introduced to improve the stability of the product once it was opened. the results of patient samples shifted by 10-14% over the entire reference interval, in contrast to the results generated with batches of reagents manufactured prior to the design change in june 2015. notwithstanding the foregoing, the performance characteristics of the additional test did not they seem affected.

Device

Access Free T3
  • Modelo / Serial
    Reference: A13422, lots 524087, 526807,528874, 529913, || 530102, 531647, 532473, 534080, 534081, 534336, 535481, || 570090, 570116, 570222, 570236, 570239, 570245, 570246, || 622173, 622174, 671016, 671025, 671033, future lots
  • Descripción del producto
    CALIBRATION AND QUANTITATIVE DETERMINATION OF RELATED ANALYTS IN SAMPLES FROM THE HUMAN BODY.
  • Manufacturer
    BECKMAN COULTER INC. || Imported by: ROCHEM BIOCARE COLOMBIA S.A./ || ANÁLISIS TÉCNICOS LTDA

Manufacturer

BECKMAN COULTER INC. || Imported by: ROCHEM BIOCARE COLOMBIA S.A./ || ANÁLISIS TÉCNICOS LTDA