Events

Recall of Device Recall Roche Cobas driver

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Data Innovations, 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
    36752
  • Event Risk Class
    Class 2
  • Event Number
    Z-0224-2007
  • Event Initiated Date
    2006-11-03
  • Event Date Posted
    2006-11-29
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-06-11
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=49266
  • 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
    analytical laboratory data interface. - Product Code JQP
  • Reason
    Software of modular driver may incorrectly report patient results as quality control results.
  • Action
    Data Innovations notified users by email listserv and by letter dated 10/25/06.

Device

Device Recall Roche Cobas driver

Manufacturer

Data Innovations, Inc.
  • Manufacturer Address
    Data Innovations, Inc., 120 Kimball Ave Ste 100, South Burlington VT 05403-6837
  • Source
    USFDA