Events

Safety Alert for D-Dimer

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by PRODUCTOS ROCHE S.A..

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
    IRD-010515
  • Event Number
    2007RD-0000685
  • Date
    2015-05-14
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=180
  • 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
    Notification by the parent company, where it is reported that on rare occasions the result of the d-dimer (d-dimer) can present a falsely high value, due to the presence in the patient sample of a high concentration of non-specific immunoglobulins of igm type.

Device

D-Dimer
  • Model / Serial
    Reference. 04912551190/04912497190
  • Product Description
    Reagents, controls and calibrators used in determinations of the coagulation area from samples of human origin
  • Manufacturer
    PRODUCTOS ROCHE S.A.

Manufacturer

PRODUCTOS ROCHE S.A.