Events

Recall of cobas 4800

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
    64930
  • Event Risk Class
    Class 2
  • Event Number
    Z-1346-2013
  • Event Initiated Date
    2013-04-01
  • Event Date Posted
    2013-05-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-08-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=117447
  • 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
    real time Nucleic acid amplification system - Product Code OOI
  • Reason
    In rare instances, channel shifted results have been generated with cobas¿ 4800 assays run on v1.1.1 of the cobas¿ 4800 system. raw data review indicates that, in these cases, all signals are shifted by one channel: channel 1 results report as channel 2, channel 2 results report as channel 3, channel 3 results report as channel 4, and channel 4 results report as channel 1. in the reported.
  • Action
    Roche sent an "Urgent Medical Device Correction" (UMDC) notification with response form dated April 1, 2013, to all affected customers via UPS Ground on April 1, 2013. The letter identified the product, the problem, and the action to be taken by the customer. A contact number (Roche Diagnostic Technical Support) is provided for technical support 24 hours a day, seven days a week at phone number: 1-888-912-7090.

Device

cobas 4800
  • Model / Serial
    Material Number 05200881001 - all lot/serial numbers.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution.
  • Product Description
    cobas¿ 4800 system z480 instrument. || Integrates fully automated total nucleic acid isolation directly from secondary sample tubes.
  • 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