Events

Safety Alert for NOVA STAT PROFILE Gas and Electrolyte Analyzer

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Nova Biomedical Corporation.

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
    I1710-499
  • Event Number
    2014DM-0011971
  • Date
    2017-10-19
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=68
  • 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

Device

NOVA STAT PROFILE Gas and Electrolyte Analyzer
  • Model / Serial
    PRIME CCS COMPLETE, specific serials.
  • Product Description
    The STAT PROFILE PRIME CCS analyzer system analyzer: is intended for in vitro diagnostic use by health professionals in clinical laboratory environments and intensive care units for the quantitative determination of PH, PCO2, PO2, HCT, NA +, K +, CL- , ICA, GLU (GLUCOSE) AND LAC (LACTATE) in heparinized whole blood, serum, plasma and urine. . In samples of critical care patients or that require these measurements for their treatment or control of the disease.
  • Manufacturer
    Nova Biomedical Corporation

Manufacturer

Nova Biomedical Corporation