Events

Safety Alert for PHOENIX GRAM NEGATIVE IDENTIFICATION PANEL

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by BECTON DICKINSON & COMPANY CON DOMICILIO EN || ESTADOS UNIDOS DE AMÉRICA. || Imported by: BECTON DICKINSON DE COLOMBIA || 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
    ARD-020916
  • Date
    2016-09-28
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=119
  • 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 sanitary agency notifies, that the company bectondickinson & company, explains that a new isolation of strains of klebsiella pneumoniae has been identified, in the gram negative panels of phoenix, this novelty can be derived from the alteration of the susceptibility test to antibiotics cefepima, present in the themselves, which can lead to a false positive result. therefore, it is recommended that laboratories configure the bdphoenix system to ensure that the configuration pattern is current, as specified in the instructions sent to the users.

Device

PHOENIX GRAM NEGATIVE IDENTIFICATION PANEL

Manufacturer

BECTON DICKINSON & COMPANY CON DOMICILIO EN || ESTADOS UNIDOS DE AMÉRICA. || Imported by: ...