Events

Safety Alert for CHEMISTRY CALIBRATORS I I

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. || Imported by: 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-041016
  • Event Number
    INVIMA 2007RD-0000603
  • Date
    2016-10-31
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=116
  • 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 healthcare agency notifies, that siemens healthcarediagnostics is carrying out a corrective action in the advia® systems, for the calibrators of the lots described in the table above, because the value assigned to the dbil_2 calibrator, provides a positive bias of approximately 41% in samples of patients, comparison with the reference method for direct labilirubin measurement, this error may result in an overestimation of the direct bilirubin concentration. as a consequence, the results of the patient sample and quality control will be shifted downward from proportionally to align with the reference methodology, beginning with the reassignment of calibrator values for lots 680726, 680726a, 680726b, 680726c, and 680726d, in this sense the ranges should be revised and adjusted.

Device

CHEMISTRY CALIBRATORS I I

Manufacturer

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