Events

Safety Alert for Leica tissue processor

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Leica Biosystems Nussloch GmBh.

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
    I1508-409
  • Event Number
    2014DM-0012120
  • Date
    2015-08-21
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=173
  • 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 that the level detection system may incorrectly report an "empty bottle" condition during filling, before completing the 5 l filling, leading to potential failure in the results of analysis of the samples and being able to require repeat the biopsies.

Device

Leica tissue processor
  • Model / Serial
    ASP6025
  • Product Description
    Only qualified personnel should use the tissue processor. The equipment has been designed in such a way that it is fault-proof - both in terms of the user and the samples to be processed - provided that the user complies at all times with the instructions in the user manual. The equipment has been designed for the following applications in the laboratory: fixation, dehydration, paraffin infiltration of histological samples.
  • Manufacturer
    Leica Biosystems Nussloch GmBh

Manufacturer

Leica Biosystems Nussloch GmBh