Events

Safety Alert for Ortho Vision analyzer

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

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
    I1603-105
  • Event Number
    2015DM-0012864
  • Date
    2016-03-15
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=151
  • 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 an unlikely scenario in which a user improperly removes or exchanges the samples in a sample rack on board or removes a dilution tray on board after making the request to load / download reagents (reagents load / unload), if an inappropriate change is made in the site of the decarga station that was not selected through the user graphic interface (gui), the system will not detect the change, which could lead to the affectation of the results obtained in the processing of the samples.

Device

Ortho Vision analyzer
  • Model / Serial
    6904578 and 6904579, serial 60002080, 60002096 and 60002277.
  • Product Description
    ORTHO VISION ANALYZER is a device designed to automate in vitro immunohematological analysis of human blood using ORTHOBIOVUE SYSTEM cassette technology. ORTHO VISION ANALYZER automates test processing functions, such as liquid pipetting, reagent handling, incubation, centrifugation, classification and interpretation of reactions and requirements for data management using cassettes and digital image processing. ORTHO VISION ANALYZER can be used as an independent device or connected to the customer's computer system (LIS).
  • Manufacturer
    Ortho Clinical Diagnostics || Tecan Schweiz Ag

Manufacturer

Ortho Clinical Diagnostics || Tecan Schweiz Ag