Events

Alerta De Seguridad para HER2 CISH pharm dx

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 DAKO || Importer: ROCHEM BIOCARE COLOMBIA S.A.S.

¿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
    RRD-090616
  • Número del evento
    INVIMA 2013RD-0002654
  • Fecha
    2016-06-29
  • 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
    Low concentrations of reagent contained in vial 3 during batch production. as a result, the concentration of the her2 test is too low, causing reduction of the quality of the coloration, according to the variability of the tissues. when her2 cish pharmdx kit, code sk109 is used in accordance with the instructions for use, blue and red discolorations are easily visible in the normal cells of the tissue sample. if these control signals are not identified in the normal cells, the results of the tests may not be conclusive for the affected flock. the inability to clearly identify such red and blue signals in normal cells indicates a failure of the evaluation and the test should be repeated with a new batch. this may cause a potential delay in diagnosis. however, if the control signals are not checked according to the instructions for use, there is a risk of erroneous diagnosis due to a false negative result.

Device

HER2 CISH pharm dx

Manufacturer

DAKO || Importer: ROCHEM BIOCARE COLOMBIA S.A.S