Events

Safety Alert for Advia Chemistry Triglycerides _2 Concentrated Re agents (TRIG_c)

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

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-070316
  • Event Number
    INVIMA 2014RD-0003060
  • Date
    2016-03-15
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=151
  • 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
    These batches do not comply with the linearity limit range included in the insert, since the products are close to the end of their useful life. internal tests performed by the parent company showed a bias of -12% to -15%, at concentration levels between 450 to 550 mg / dl, and linearity is reduced by approximately 31% when higher triglyceride concentrations exist, up to 1200mg / dl ( 13.56mmol / l). the above can generate a misinterpretation of very high triglyceride values. however, when considering an alternative treatment, triglyceride values should be used together with other lipid parameters and the patient's medical history.

Device

Advia Chemistry Triglycerides _2 Concentrated Re agents (TRIG_c)
  • Model / Serial
    Catalog Reference: 10697575; lots: 348297 and 359932
  • Product Description
    DETERMINATION OF DIFFERENT ANALYTICS RELATED TO SAMPLES FROM THE HUMAN ORGANIZATION
  • Manufacturer
    RANDOX LABORATORIES || Importer: SIEMENS S.A

Manufacturer

RANDOX LABORATORIES || Importer: SIEMENS S.A