Events

Recall of Device Recall Roche Molecular Diagnostics Inc.

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Roche Molecular Systems, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    70355
  • Event Risk Class
    Class 3
  • Event Number
    Z-1320-2015
  • Event Initiated Date
    2015-01-13
  • Event Date Posted
    2015-03-25
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-12-11
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=133247
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Somatic gene mutation detection system - Product Code OWD
  • Reason
    False positive results for exon 20 insertion mutations are being detected with the cobas¿ egfr mutation test, kit batch t08661.
  • Action
    RMS notified their customers on 1/13/2015.

Device

Device Recall Roche Molecular Diagnostics Inc.

Manufacturer

Roche Molecular Systems, Inc.
  • Manufacturer Address
    Roche Molecular Systems, Inc., 1080 Us Highway 202 S, Branchburg NJ 08876-3733
  • Manufacturer Parent Company (2017)
    Roche Holding AG
  • Source
    USFDA