Events

Alerta De Seguridad para AGAR CHROMID MRSA (MRSA)

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 BIOMERIEUX S.A || Importer: BIO MERIEUX 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
    RRD-020616
  • Número del evento
    INVIMA 2007RD-0000448
  • Fecha
    2016-06-03
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=138
  • 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
    Changes in the appearance of the agar in the affected lots due to a failure in the sedimentation of the particles by defects of raw material, affecting the color of the agar and giving it a pale appearance. this aspect can sometimes be detected by the user before use. this problem has no impact on microbial growth, however the coloration of the small colonies can be delayed (colorless appearance after incubation 18h and pink or red color after 24 hours ). therefore, if this defect is not detected before use, colorless colonies may appear instead of pink or red after 18 hours of incubation, presenting the risk of misinterpretation of the result as small, colorless, negative colonies after 18h incubation. .

Device

AGAR CHROMID MRSA (MRSA)
  • Modelo / Serial
    Reference: 413050, Lot: 1004727550, 1004746750 || Reference: 413051, Lot: 1004746760
  • Descripción del producto
    ISOLATION, SCREENING AND TRANSPORTATION OF MICROORGANISMS.
  • Manufacturer
    BIOMERIEUX S.A || Importer: BIO MERIEUX COLOMBIA

Manufacturer

BIOMERIEUX S.A || Importer: BIO MERIEUX COLOMBIA