Events

Safety Alert for THIOGLYCOLATE BROTH WITH RESAZURINE (THIO-T)

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by BIOMERIEUX S.A FRANCIA || Importer: BIOMERIEUX COLOMBIA SAS.

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-030216
  • Event Number
    INVIMA 2008RD-0001143
  • Date
    2016-02-10
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=157
  • 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
    Change in the yield of this batch, giving rise to the random growth in the cultures of staphylococcus aureus, strain nctc 1078 and staphylococcus aureus, strain atcc 7538, as well as the absence of growth in the cultures of bacillus subtilis, strain atcc 6633. this alteration in the performance can lead to false negatives both for the cultivation of aerobic control strains and for strains of clinical origin.

Device

THIOGLYCOLATE BROTH WITH RESAZURINE (THIO-T)

Manufacturer

BIOMERIEUX S.A FRANCIA || Importer: BIOMERIEUX COLOMBIA SAS