Events

Safety Alert for IMMULITE IGF-I (IG1)

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-010516
  • Event Number
    INVIMA 2006RD-0000064
  • Date
    2016-05-02
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=144
  • 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
    To reach the equilibrium of the test, the incubation time in the pre-treatment of the samples with the lgfa solution is 24 minutes. if the patient samples are processed before reaching a total equilibrium, a recovery deficit of up to -36% may be present. if the sample is incubated for more than 24 minutes, no low recovery levels are observed.

Device

IMMULITE IGF-I (IG1)

Manufacturer

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