Events

Safety Alert for Immunoassay System

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
    I1704-145
  • Event Number
    2007DM-0001161
  • Date
    2017-04-27
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=92
  • 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 reports that a circuit board that controls the motor functions of the referenced devices can affect its positioning in the pipette belt and the incubator while the instrument is in operation, which could lead to delays in the processing of the samples and alteration of the results.

Device

Immunoassay System
  • Model / Serial
  • Product Description
    Performs analysis of plasma and serum samples.
  • Manufacturer
    Beckman Coulter Inc

Manufacturer

Beckman Coulter Inc