Events

Safety Alert for calibration solutions 1 AND 2./CAL Pack

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by RADIOMETER MEDICAL A.P.S || Importer: INSTRUMENTACION 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
    RRD-050216
  • Event Number
    INVIMA 2008RD-0000917
  • Date
    2016-02-26
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=154
  • 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
    Potential risk of false negative results when using the reference test kits no. 942-940 for the aqt90flex analyzer and the reference cartridges cal 944-268. the above is due to improper placement of the aluminum films, which affect the absorption capacity of the cartridge component, resulting in premature wear of the product. additionally, this defect can also affect the stability of the reagents contained in the wells of the cartridges, which are susceptible to moisture.

Device

calibration solutions 1 AND 2./CAL Pack

Manufacturer

RADIOMETER MEDICAL A.P.S || Importer: INSTRUMENTACION S.A