Events

Safety Alert for Cobas EGRF Mutation Test and Cobas cfDNA Sample Preparation Kit

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by ROCHE MOLECULAR SYSTEMS || 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
    IRD-030416
  • Event Number
    INVIMA 2015RD-0003495
  • Date
    2016-04-13
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=147
  • 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
    During internal studies using artificial plasma, several mutations (l858r, deletions of exon 19, t790m) generate inconsistently the result "mutation not detected" (which could be considered as false negative) with the kitcobas® egfr mutation test, v2 when used in set with the cobas® cfdna sample preparation kit. the internal research carried out by our parent company suggests that the combination of the glass fiber mesh of the column with the substances of the wash buffer reagent are the primary responsible for the observed inhibition.

Device

Cobas EGRF Mutation Test and Cobas cfDNA Sample Preparation Kit
  • Model / Serial
    Cobas EGRF Mutation Test: reference: 07248563190, all || lots. || Cobas cfDNA Sample Preparation Kit: reference: 07247737190, || all lots.
  • Product Description
    DETERMINATION OF DIFFERENT ANALYTICS RELATED TO SAMPLES FROM THE HUMAN ORGANIZATION
  • Manufacturer
    ROCHE MOLECULAR SYSTEMS || Importer: PRODUCTOS ROCHE S.A

Manufacturer

ROCHE MOLECULAR SYSTEMS || Importer: PRODUCTOS ROCHE S.A