Events

Safety Alert for Elecsys digitoxin

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by ROCHE DIAGNOSTICS GMBH || Importer: 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
    RRD-060416
  • Event Number
    INVIMA 2006RD-0000231
  • Date
    2016-04-20
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=146
  • 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
    Strong dispersion of results in patient samples. the internal investigation carried out by our parent company has identified a change in the specificity of the antibody as the main cause of the reported problem. for digoxin and digoxin-type drugs the cross-reactivity was significantly increased (approximately 200% cross-reactivity for digoxin) which means that for approximately 1ng / ml of digoxin present in the sample the result of digitoxin will be elevated by approximately 2ng / ml.

Device

Elecsys digitoxin
  • Model / Serial
    References: 03374670190, 20753599322, 05841283190, lots: || 72199322, 11968401, 61304301, 61598601, 61304001, || 61598301
  • Product Description
    REAGENTS, CALIBRATORS AND CONTROLS USED FOR THE DETERMINATION OF DIGOXIN FROM DEMONSTRATION OF HUMAN ORIGIN.
  • Manufacturer
    ROCHE DIAGNOSTICS GMBH || Importer: PRODUCTOS ROCHE S.A.

Manufacturer

ROCHE DIAGNOSTICS GMBH || Importer: PRODUCTOS ROCHE S.A.