Events

Safety Alert for Diagnostic Test Analysis Systems

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Tecan Schweiz Ag || Ortho Clinical Diagnostics || Ortho Clinical Diagnostics.

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
    I1701-15
  • Event Number
    2015DM-0012864
  • Date
    2017-01-25
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=106
  • 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 has detected that if the incubation time parameters are changed when creating a user defined protocol (udp) test, then the incubation time of the ortho test template and other udp tests created from the same template the test can change, leading to errors in the processing, obtaining deviations from the results.

Device

Diagnostic Test Analysis Systems
  • Model / Serial
  • Product Description
    ORTHO VISION ANALYZER is a device designed to automate in vitro immunohematological analysis of human blood using ORTHO BIOVUE SYSTEM cassette technology .ORTHO VISION ANALYZER automates the functions of test processing, such as liquid pipetting, reagent handling, incubation, centrifugation, classification and interpretation of the reactions and the requirements for the management of data by means of cassettes and digital image processing.ORTHO VISION ANALYZER can be used as an independent team or connected to the computer system of the client's laboratory (lis).
  • Manufacturer
    Tecan Schweiz Ag || Ortho Clinical Diagnostics || Ortho Clinical Diagnostics

Manufacturer

Tecan Schweiz Ag || Ortho Clinical Diagnostics || Ortho Clinical Diagnostics
  • Source
    NIDFSINVIMA