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 || Leica Instruments Singapore Pte Limited || Leica Microsystems Ltd. Shanghai.

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
    I1706-241
  • Event Number
    2017DM-0016252 ; 2014DM-0012120
  • Date
    2017-06-21
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=82
  • 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 informs that the referenced devices could have an incorrect labeling with respect to the voltage specified for the alarm connector on the back of the equipment, the correct information is 30va.C, however the current labels specify125va.C as maximum voltage, leading to there are electrical risks and possible adverse events on users.

Device

Leica tissue processor

Manufacturer

Leica Biosystems Nussloch Gmbh || Leica Instruments Singapore Pte Limited || Leica Microsystems L...