Events

Safety Alert for cobas EGFR Mutation Test, v2 CE- IVD and cobas cfDNA Sample Preparation Kit

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Roche Diagnostics.

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
  • Date
    2016-04-18
  • Event Date Posted
    2016-04-18
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20160418c.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: roche diagnostics cobas egfr mutation test, v2 ce- ivd and cobas cfdna sample preparation kit medical device manufacturer, roche diagnostics, has issued a medical device safety alert concerning its cobas egfr mutation test, v2 ce- ivd and cobas cfdna sample preparation kit. according to the manufacturer, several mutations (l858r, exon 19 deletion, t790m) inconsistently generated “no mutation detected” (i.E. false negative) results with the cobas egfr mutation test, v2 when utilising the cobas cfdna sample preparation kit during internal studies using contrived plasma specimens. there is no impact when using the cobas dna sample preparation kit with the cobas egfr mutation test, v2 to test formalin-fixed paraffin-embedded tumour (ffpet) tissue samples. patients with a false negative result for the mutations may be denied the prospect of prolongation of disease control and survival (8-12 months). the manufacturer will update the instructions for use (ifu) for the cobas egfr mutation test, v2 and cobas cfdna sample preparation kit to revise the handling of the eluate for plasma specimens prior to amplification and detection. users are advised to follow the revised instruction until the updated ifu become available. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 18 april 2016.

Device

cobas EGFR Mutation Test, v2 CE- IVD and cobas cfDNA Sample Preparation Kit
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Roche Diagnostics cobas EGFR Mutation Test, v2 CE- IVD and cobas cfDNA Sample Preparation Kit
  • Manufacturer
    Roche Diagnostics

Manufacturer

Roche Diagnostics