Events

Safety Alert for Glucose Oxidase GLUO Triglycerides_2 TRIG_2Triglycerides_2 Concentrated TRIG_cUric Acid UALDL Cholesterol Direct DLDLDirect HDL Cholesterol D-HDLLactate LAC

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by SIEMENS HEALTHCARE DIAGNOSTICS INC || 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
    IRD-020416
  • Event Number
    INVIMA 2009RD-0001332 ; INVIMA 2008RD-0001045 ; INVIMA 2006RD-0000271 ; INVIMA 2006RD-0000261
  • Date
    2016-04-11
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=148
  • 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 reagents in question are used in tests that are based on the trinder reaction, a colorimetric reaction between hydrogen peroxide, a phenol derivative and an amino-antipyrin catalyzed in the presence of peroxidase, this reaction acetylcysteine (nac) and metamizole, therefore , the samples analyzed and containing the drugs in question can generate falsely low results.

Device

Glucose Oxidase GLUO Triglycerides_2 TRIG_2Triglycerides_2 Concentrated TRIG_cUric Acid UALDL Cho...
  • Model / Serial
    Glucose Oxidase GLUO: catalog 74020, all batches || Triglycerides_2 TRIG_2: catalog 74082, all lots || Triglycerides_2 Concentrated TRIG_c: catalog 74084, all || lots || Uric Acid UA: catalog 74021, all batches || LDL Cholesterol Direct DLDL: catalog 74028, all batches || Direct HDL Cholesterol D-HDL: catalog 74073, all batches || Lactate LAC: catalog 74051 can be altered by medications containing N-
  • Product Description
    DETERMINATION OF RELATED ANALYTICS IN SAMPLES FROM THE HUMAN ORGANISM
  • Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC || Importer: SIEMENS S.A.

Manufacturer

SIEMENS HEALTHCARE DIAGNOSTICS INC || Importer: SIEMENS S.A.
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    NIDFSINVIMA