Events

Safety Alert for photometric analyzer - Hemocue / microcuvettes

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

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
    I1412-501
  • Event Number
    2014DM-0012197
  • Date
    2014-12-04
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=190
  • 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 manufacturer states that the referenced microcuvettes can produce glucose measurements higher than the real, leading to possible adverse events on patients.

Device

photometric analyzer - Hemocue / microcuvettes
  • Model / Serial
    Glucose 201, reference Microcuvettes 110715, 110716, 110717, 110718, 110719 and 110720, specific lots
  • Product Description
    The analyzer systems are indicated for the quantitative determination of parameters in total capillary or venous blood samples. The systems are intended solely for in vitro diagnosis.
  • Manufacturer
    Hemocue Ab

Manufacturer

Hemocue Ab