Events

Safety Alert for System for Processing Pathology Samples - PREP STAIN SYSTEM

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Becton Dickinson and Company || Tripath Imaging, Inc..

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    R1603-95
  • Event Number
    2015DM-0012996
  • Date
    2016-03-09
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=153
  • Notes / Alerts
    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.
  • Extra notes in the data
  • Reason
    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
  • Model / Serial
    490527, lots 5141835, 5139714 and 5099700.
  • Product Description
    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.