Events

Safety Alert for Vitros chemistry products COCM Reagent

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Ortho Clinical Diagnostic 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
    R-RD-01-10-13.
  • Event Number
    2007RD-0000428.
  • Date
    2013-10-17
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=214
  • 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
    Tending towards readings below what was expected both for quality control and for patients.

Device

Vitros chemistry products COCM Reagent
  • Model / Serial
  • Product Description
    Calibration and semiquantitative or qualitative determination of the related analyte.
  • Manufacturer
    Ortho Clinical Diagnostic INC.

Manufacturer

Ortho Clinical Diagnostic INC.