Events

Safety Alert for cellular analysis systems Beckman Coulter

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
    I1705-170
  • Event Number
    2009DM-0003984
  • Date
    2017-05-16
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=88
  • 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 there is a possibility of an interruption of data acquisition that may cause an unusual light scattering event pattern for the white blood cell differential, which may not have a system indicator and / or associated message, events related to the unusual light scattering pattern can be incorrectly removed from the analysis, which may result in an erroneous differential result of the samples.

Device

cellular analysis systems Beckman Coulter
  • Model / Serial
    UniCel DxH 800 - 629029, B24465, B24802, B68304, B66445, B63322 and UniCel DxH 600 - B23858
  • Product Description
    Automated equipment to perform cell hematological analysis, blood count with counts and differential leukocyte.
  • Manufacturer
    Beckman Coulter Inc

Manufacturer

Beckman Coulter Inc