Events

Safety Alert for Vitros 5600 Johnson integrated 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
    A1605-211
  • Event Number
    2009DM-0003172
  • Date
    2016-05-10
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=142
  • 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 the presence of positively biased results using vitros total b-hcg ii immunodiagnostic reagent packages, which may lead to potentially serious adverse events occurring to the patient due to the bias of the result obtained.

Device

Vitros 5600 Johnson integrated system
  • Model / Serial
    Concerning calibration discs reference 6801876, Release version of data 5873, 5874, 5875 and 5876.
  • Product Description
    This equipment is indicated for use in in vitro diagnostics in quantitative, semiquantitative and qualitative in vitro measurement of different analytes of clinical interest.
  • Manufacturer
    Orthoclinical Diagnostics, Inc.

Manufacturer

Orthoclinical Diagnostics, Inc.