Events

Safety Alert for antimicrobial susceptibility discs penicillin G (P1)

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by THERMOFISHER SCIENTIFIC – OXOID || Importer: QUIMICOS Y REACTIVOS LTDA “QUIMIREL || LTDA”.

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
    RRD-021215
  • Event Number
    INVIMA 2007RD-0000682 ; INVIMA 2011RD-0001919 ; INVIMA 2013RD-0002455
  • Date
    2015-12-02
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=165
  • 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
    This batch of product may contain a small number of discs that produce variable results, all batches are not affected, however it was identified that the size of the inhibition zone varies significantly with some discs producing greater than expected zones of inhibition or irregular.

Device

antimicrobial susceptibility discs penicillin G (P1)

Manufacturer

THERMOFISHER SCIENTIFIC – OXOID || Importer: QUIMICOS Y REACTIVOS LTDA “QUIMIREL || LTDA”