Events

Safety Alert for Flow cytometer for in vitro diagnosis

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Beckman Coulter Ireland Inc || 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
    I1610-425
  • Event Number
    2016DM-0014667
  • Date
    2016-10-07
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=118
  • 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 use of the reagent cart in the referenced devices can lead to misalignment of the carousel and damage to the preparation probe, leading to delays in the analysis of the samples.

Device

Flow cytometer for in vitro diagnosis
  • Model / Serial
    AQUIOS CL - B30166, serial AY03004, AY20032, AY25038, AY47063, AY47071, AY51072, AY51075, AZ12027, AZ12030, || AZ12033, AZ15038, AZ15044, AZ19046, AZ19047, AZ19052.
  • Product Description
    Flow cytometer for in vitro diagnosis.
  • Manufacturer
    Beckman Coulter Ireland Inc || Beckman Coulter Inc

Manufacturer

Beckman Coulter Ireland Inc || Beckman Coulter Inc