Events

Safety Alert for automated equipment for immunochemical analysis

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

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
    I1503-115
  • Event Number
    2010DM-0005321
  • Date
    2015-03-13
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=183
  • 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 that has developed the software updates for the systems referenced versions 6.2.2 and 3.4.2 respectively, to control and detect the reagent packs with insufficient volume, inadequately loaded or missing, avoiding delays in the processing of the samples.

Device

automated equipment for immunochemical analysis
  • Model / Serial
    DxC 600i and Access 2
  • Product Description
    Automated equipment for in vitro immunochemical analysis in a clinical laboratory.
  • Manufacturer
    Beckman Coulter Inc.

Manufacturer

Beckman Coulter Inc.