Events

Alerta De Seguridad para System for Processing Pathology Samples - PREP STAIN SYSTEM

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 Becton Dickinson and Company || Tripath Imaging, Inc..

¿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
    R1603-95
  • Número del evento
    2015DM-0012996
  • Fecha
    2016-03-09
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=153
  • 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 manufacturer has detected that the caps of somesurepath vials are cracked at the top and are subsequently being filtered after the sample collection, customers have also noticed the same problem with a kit before use, leading to potentially adverse events with the patients or users.

Device

System for Processing Pathology Samples - PREP STAIN SYSTEM
  • Modelo / Serial
    490527, lots 5141835, 5139714 and 5099700.
  • Descripción del producto
    The PREP STAIN SYSTEM is a device that is used for the preparation and processing of cytologies and cervical samples for pathology analysis. The team performs all the steps after taking the cervical sample. The mixture, homogenizes it, dispenses it in the glass slides, adds the reagents and the dyes to leave it ready for reading by optical microscopy by the doctor or pathology technologist. This team does not report results of the samples, it only processes the cervical samples.
  • Manufacturer
    Becton Dickinson and Company || Tripath Imaging, Inc.

Manufacturer

Becton Dickinson and Company || Tripath Imaging, Inc.