Events

Safety Alert for Fluorometer - PHADIA 250

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Phadia Ab.

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
    I1704-144
  • Event Number
    2011DM-0007347
  • Date
    2017-04-27
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=91
  • 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 reports that he has received reports of malfunction due to deformed bottles that can cause an erroneous volume detection by the instrument that will result in insufficient aspiration of sample diluent, thus generating insufficient dilution of patient samples and the error code "3- 145 right arm of liquid detection below the lower limit with objective 2 ", which could lead to delays in the processing of the samples and alteration of the results.

Device

Fluorometer - PHADIA 250
  • Model / Serial
  • Product Description
    Automated processing of serum samples.
  • Manufacturer
    Phadia Ab

Manufacturer

Phadia Ab