Events

Alerta De Seguridad para LIFECODES HLA-C eRES SSO

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 IMMUCOR TRANSPLANT DIAGNOSTICS, INC || Importer: BIOSCIENCES 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
    IRD-010616
  • Número del evento
    INVIMA 2014RD-0002729
  • 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
    The threshold set for probes 380, 382, 384 and 385 are high insertion and may result in false negative results. probe 380 resolves allele c * 03: 06, probe 382 resolves allele c * 12: 3, probe 384 solves allele c * 01:08 and probe 385 solves allele c * 08: 06. the risk for the patient is considered low, due to the low frequency of the alleles that are detected by these probes. due to the complex nature of hla, qualified personnel should review the interpretation of the data and results of the labeling, in accordance with the limitations of the procedure in the insert of the product.

Device

LIFECODES HLA-C eRES SSO

Manufacturer

IMMUCOR TRANSPLANT DIAGNOSTICS, INC || Importer: BIOSCIENCES S.A.S
  • Empresa matriz del fabricante (2017)
    Grifols Sa
  • Source
    NIDFSINVIMA