Events

Safety Alert for ADVIA T4

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 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-060716
  • Event Number
    INVIMA 2007RD-0000554
  • Date
    2016-07-22
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=131
  • 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
    Siemens healthcare diagnostics is currently investigating confirmed reports of faults in the calibration slopes in the advia® centaur systems t4 reagent lots listed in table 1. an error in the calibration slope will result in an invalid calibration status that will prevent t4 results from being generated from patients if the calibration is valid and the controls are within laboratory limits, the results of the patient samples are considered valid and may be reported.

Device

ADVIA T4
  • Model / Serial
    Reference 110735 - 100 Test code SMN 10309960 || Reference110736 - 500 Test, SMN code: 10309961. Lots: || 54960167, 55653167, 80879168, 84500168, 01339169, || 03568169, 03828169, 25026170, 26026170, 54961167, || 55015167, 55588167, 79714168, 84353168, 01338169, || 04003169, 06500169, 13480169, 25777170, 29403170, || 38704170
  • Product Description
    QUANTITATIVE DETERMINATION OF RELATED ANALYTS IN SAMPLES FROM THE HIMANO ORGANISM
  • Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC || Importer: SIEMENS HEALTHCARE COLOMBIA

Manufacturer

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