Events

Safety Alert for antimicrobial susceptibility test etest piperacilline / tazobactam 4 PTC 256

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 || Importer BIOMERIEUX COLOMBIA S.A.S.

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-031215
  • Event Number
    INVIMA 2009RD-0001247
  • Date
    2015-12-11
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=164
  • 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
    False sensitive results after submitting enterobacteria strains to tests with gel dedilution reference methods and microdilution in liquid medium, using the eucast critical concentrations (cmi <0u = 8: sensitive, cmi> 16: resistant). the risk to the patient is obtaining the potentially wrong result, in particular the result is falsely sensitive, directly influencing the medical decision in the selection of antibiotic therapy.

Device

antimicrobial susceptibility test etest piperacilline / tazobactam 4 PTC 256

Manufacturer

BIOMERIEUX S.A || Importer BIOMERIEUX COLOMBIA S.A.S