Events

Recall of COBAS INTEGRA 800 Analyzer

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Roche Diagnostics Operations, 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
    66239
  • Event Risk Class
    Class 2
  • Event Number
    Z-0168-2014
  • Event Initiated Date
    2013-09-16
  • Event Date Posted
    2013-11-05
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-05-12
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=121816
  • 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
    Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
  • Reason
    Roche cobas integra 800 system, software version 9864.C2 does not perform necessary ise service actions. whenever the ise rack is removed, the ise counters in the software are reset to zero and the corresponding service actions are not conducted automatically by the system. additionally, certain maintenance activities that have to be performed manually by the operator are not requested on the sof.
  • Action
    Roche sent an Urgent Medical Device Correction letter dated September 16, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Roche Diagnostics recommends tracking all ISE counters and manually requesting the corresponding Service Actions listed in the notification be monitored until updated software becomes available during Q4 2013. If the affected product was moved to another site, the notification is to be forwarded. consignees were asked to complete the attached faxback form and fax it to 1-877-266-0997 and file the Urgent Medical Device Correction (UMDC) for future reference. Question should be directed to Roche Support Network Customer Support Center 24 hours a day, seven days a week at 1-800-428-2336 For questions regarding thisr ecall call 317-576-3911.

Device

COBAS INTEGRA 800 Analyzer
  • Model / Serial
    software version 9864.C2
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution and Puerto Rico
  • Product Description
    COBAS INTEGRA 800 Analyzer with software 9864.C2 || Cobas. COBAS Part Numbers 28122474001, 28122474692, 04559126001, 04589459970 corresponding to the Analyzer with or without closed tube sampling accessory || A fully automated system for clinical chemistry analysis intended for the in vitro quantitative/qualitative determination of analytes in body fluids.
  • Manufacturer
    Roche Diagnostics Operations, Inc.

Manufacturer

Roche Diagnostics Operations, Inc.
  • Manufacturer Address
    Roche Diagnostics Operations, Inc., 9115 Hague Rd, Indianapolis IN 46256-1025
  • Manufacturer Parent Company (2017)
    Roche Holding AG
  • Source
    USFDA