Events

Safety Alert for ACCES BR MONITOR (CA 15-3)

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. || Imported by: ROCHEM BIOCARE COLOMBIA S.A. || ANALISIS TECNICOS LTDA..

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
    IRD-010417
  • Event Number
    INVIMA 2008RD-0001104
  • Date
    2017-04-21
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=93
  • 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 health agency notifies that beckman coulter, has informed about the bias observed in the quality control, where it was evidenced that the results of the tests of the access br monitor monitor, are being generated inferior therein reference reference superior 31.3 u / ml, for those patients that are referred with breast cancer.

Device

ACCES BR MONITOR (CA 15-3)

Manufacturer

BECKMAN COULTER INC. || Imported by: ROCHEM BIOCARE COLOMBIA S.A. || ANALISIS TECNICOS LTDA.