Events

Safety Alert for Vitros 3600 Johnson immunodiagnostic system

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Orthoclinical Diagnostics, 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
    A1605-183
  • Event Number
    2009DM-0003375
  • Date
    2016-05-03
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=143
  • 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 potential anomaly in the synchronization of the referenced system software may cause sample processing to yield erroneous results, which can potentially lead to serious adverse events on the patient.

Device

Vitros 3600 Johnson immunodiagnostic system
  • Model / Serial
    6802783, Software Version 3.2.2 and earlier.
  • Product Description
    This equipment is designed for the quantitative, semiquantitative and qualitative measurement of a great variety of analytes of clinical interest.
  • Manufacturer
    Orthoclinical Diagnostics, Inc.

Manufacturer

Orthoclinical Diagnostics, Inc.