Events

Alerta De Seguridad para Xpert® HIV-1 Viral I II

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 CEPHEID AB || Imported by: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-030916
  • Número del evento
    INVIMA 2015RD-0003345.
  • Fecha
    2016-09-27
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=120
  • 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 sanitary agency notifies, that the cepheid manufacturer has received reports that some of the clients have had problems of performance of the cartridges, where the curve of the amplification pattern of the pcr, is abnormal, which can generate invalid results, incorrect quantification of arnvih-1, use this test. therefore, cephied will provide product replacement gxhiv-vl-ce-10 lot 1000034821 (cartridge lot 14001) or gxhiv-vl-ce-10 lot 1000036280 (cartridge lot 14002) to customers who have inventory referenced lots. it is not recommended to give a final disposition of the product, which is found in inventory.

Device

Xpert® HIV-1 Viral I II
  • Modelo / Serial
    CATALOG: GXHIV-VL-CE-10 || LOT: 1000034821 (CARTRIDGE LOT 14001) || GXHIV-VL-CE-10 LOT. 1000036280 (CARTRIDGE LOT 14002).
  • Descripción del producto
    DIAGNOSTIC TEST DESIGNED FOR THE QUICK QUANTIFICATION OF HUMAN HIV-1 TYPE VIRUS (HIV-1) IN PLASMAHUMAN FROM PERSONS INFECTED WITH HIV-1 ON THE INTERVAL OF 40 TO 10,000,000COPIAS / ML AND IS VALIDATED FOR ALL THE SUBTHPOSES OF A, B, C, D, AE, F, G, H, AB, AG, J YK OF GROUP M OF GROUPS NY O.
  • Manufacturer
    CEPHEID AB || Imported by:ROCHEM BIOCARE COLOMBIA || S.A.S

Manufacturer

CEPHEID AB || Imported by:ROCHEM BIOCARE COLOMBIA || S.A.S