Events

Recall of Device Recall Roche Molecular Systems

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
    73703
  • Event Risk Class
    Class 2
  • Event Number
    Z-1830-2016
  • Event Initiated Date
    2016-03-15
  • 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=144781
  • 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
    An error was found within the hungarian translations of the cobas¿ egfr mutation test v2 instructions for use (m/n 07340761001-01hu, doc rev. 1.0, dated 08/2015) and the cobas¿ cfdna sample preparation kit instructions for use (m/n 07573758001-01hu, doc. rev. 1.0, dated 05/2015).
  • Action
    Roche Molecular Diagnostics Inc. issued an Urgent Field Safety Notice dated March 15, 2016 to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Actions to be taken by the customer: " If you have utilized 2 ¿L of DNA PBB during testing of plasma specimens, the samples must be retested using the correct volume (2mL DNA PBB). Communication of this Field Safety Corrective Action This notice must be passed on to all those who need to be aware within your organization or to any organization/individual where the potentially affected devices have been distributed/supplied. Please maintain awareness of this notice and resulting action for an appropriate period to ensure the effectiveness of the corrective action. The undersigned confirms that this notice has been notified to the appropriate Regulatory Agency. For questions regarding this recall call 908-253-7200.

Device

Device Recall Roche Molecular Systems
  • Model / Serial
    EGFR v2: 07248563190 cfDNA: 07247737190
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Hungary
  • Product Description
    cobas¿ EGFR Mutation Test, v2 and cobas¿ cfDNA Sample || Preparation Hungarian Translation Instructions for Use
  • Manufacturer
    Roche Molecular Systems, 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