Events

Recall of Roche cobas 6000 analyzer (cobas c 501 and cobas e 601)

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

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
    51561
  • Event Risk Class
    Class 2
  • Event Number
    Z-1394-2009
  • Event Initiated Date
    2009-04-01
  • Event Date Posted
    2009-05-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-12-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=80700
  • 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
    Calculator/data processing module, for clinical use - Product Code JQP
  • Reason
    Some data alarm flags do not transfer from the analyzer to the laboratory information system, since not all data flags are recognized by the instrument manager/middleware.
  • Action
    Consignees were notified by "Urgent Medical Device Correction" letter dated April 1, 2009 and instructed to add error codes to the Instrument Manager driver and to contact the manufacturer of their LIS for instructions on adding data alarm codes to the LIS. Consignees were also instructed to complete the attached fax form after adding the error codes to their system and fax to 1-888-345-4690. Contact Roche Diagnostics Technical Support at 1-800-428-2336 for questions about information contained in the notification letter.

Device

Roche cobas 6000 analyzer (cobas c 501 and cobas e 601)
  • Model / Serial
    All units.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution.
  • Product Description
    Roche cobas 6000 analyzer series (including cobas c 501 and cobas e 601 modules) Middleware Solutions Instrument Manager Server as follows: v.8.04.02.10, catalog no. 04785568001; v.8.04.03.01, catalog no. 04785568002; and v.8.06.02, catalog no. 05109019001. || The device is used to interface hospital LIS systems with Roche c 6000 analyzers and allows order and result communication to occur between the two systems.
  • Manufacturer
    Roche Diagnostics Corp.

Manufacturer

Roche Diagnostics Corp.
  • Manufacturer Address
    Roche Diagnostics Corp., 9115 Hague Rd, Indianapolis IN 46256-1025
  • Source
    USFDA