Events

Safety Alert for CREATININE FLEX® REAGENTS CARTRIDGE (CREA)

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 / SIEMENS || HEALTHCARE COLOMBIA.

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-010716
  • Event Number
    INVIMA 2006RD-0000116
  • Date
    2016-07-01
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=134
  • 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
    Negative bias, causing low results in the range of analytical (amr) urine. this drawback results in the impossibility of reaching the required quantification limit (5 mg / dl [442 mg / dl]) for urine samples. however, the observed bias for urine samples at creatinine concentrations below 13 mg / dl has no impact on the clinical interpretation of the calculation of the glomerular filtration rate or on the clinical interpretation of laboratory tests using creatinine as a correction factor in the calculation of albumin and proteins in urine.

Device

CREATININE FLEX® REAGENTS CARTRIDGE (CREA)
  • Model / Serial
    CATALOG DF33B, CODE SMN10872079, All batches and || future lots || CATALOG K1033A CODE SMN 10872082 All batches and || future lots
  • Product Description
    THESE 15 PRODUCTS ARE USED TO MAKE TESTS OF BLOODY CHEMISTRY OF SAMPLES PROPOSED BY THE HUMAN BODY.
  • Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS / SIEMENS || HEALTHCARE COLOMBIA

Manufacturer

SIEMENS HEALTHCARE DIAGNOSTICS / SIEMENS || HEALTHCARE COLOMBIA
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    NIDFSINVIMA