Events

Safety Alert for ADVIA Tnl -ULTRA

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-070516
  • Event Number
    INVIMA 2007RD-0000558
  • Date
    2016-05-18
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=140
  • 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
    Change in the results greater than 10% in samples with biotin levels of up to 10 ng / ml (41 nmol / l). the test insert states that samples containing up to 10ng / ml (41 nmol / l) of biotin show a change in results of less than or equal to 10%. the level of biotin in the general population is approximately 0.3 to 1.0 ng / ml (1.2a 4.3 nmol / l). internal research at siemens has shown changes in tni-ultra concentrations in samples with biotin concentrations of 1.0 ng / ml, 2.5 ng / ml, 5 ng / ml, 10 ng / ml and 20 ng / ml. however, no impact on diagnosis or treatment is expected, as the ability of the trial to detect increases or decreases in troponin is not affected.

Device

ADVIA Tnl -ULTRA
  • Model / Serial
    Catalog 02789602, SMN 10317708, lots: 24483099, 28137099, || 36527099, 42516099, 46626101, 59655103, 53539104, || 72936105, 81676105, 89385106, 94642106 || C atogue 02790309, SMN: 10317709, lots: 24479099, || 26294099, 43205101, 46929101, 57805103, 65432103, || 52590104, 73322105, 80480105, 86319106, 94250106
  • Product Description
    REAGENTS, CONTROLS AND CALIBRATORS USED FOR THE DETERMINATION OF ANALYZES OF THE DEMOCRATIC AREA FROM HUMAN SAMPLES, THESE REAGENTS ARE USED WITH ADVACENTAUR, ADVIA CENTAUR CP, ADVIA CENTAUR XP EQUIPMENT.
  • 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