Events

Safety Alert for Glucose (GOD-POD); Cholesterol; Enzymatic Creatinine; HDL Cholesterol Plus; Uric acid (AOX); Triglycerides

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Thermo Fisher Scientific || Importer: VELEZ LAB 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
    IRD-031015
  • Event Number
    INVIMA 2006RD-0000176 ; INVIMA 2006RD-0000204
  • Date
    2015-09-30
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=170
  • 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
    Interferences of drugs such as n-acetylcysteine, acetaminophen, through its metabolite n-acetyl-p-benzoquinone-imine (napq) and metamizole in the reactions of type trinder, chemical photometric methodology with which work the products listed above. this inter-reference can lead to falsely low results in the measured analytes.

Device

Glucose (GOD-POD); Cholesterol; Enzymatic Creatinine; HDL Cholesterol Plus; Uric acid (AOX); Trig...
  • Model / Serial
    Glucose (GOD-POD): 981379,981780 || Cholesterol: 981812,981813 || Enzymatic Creatinine: 981845,981896 || HDL Cholesterol Plus: 981824,981823 || Uric Acid (AOX): 981391, 981788 || Triglycerides: 981301, 981786
  • Product Description
    Blood chemistry tests
  • Manufacturer
    Thermo Fisher Scientific || Importer: VELEZ LAB S.A.S

Manufacturer

Thermo Fisher Scientific || Importer: VELEZ LAB S.A.S