Events

Recall of Device Recall Cobas c8000 Modular Analyzer Series Cobasc502

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
    67762
  • Event Risk Class
    Class 2
  • Event Number
    Z-1449-2014
  • Event Initiated Date
    2014-03-13
  • Event Date Posted
    2014-04-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=126243
  • 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
    The initial cassette volume check (icvc) is not activated on the cobas c 502 module of the cobas 8000 modular analyzer series when manually filled cobas c packs are loaded. this issue occurs with tests that use cobas c pack multi or empty pre-labeled cobas c packs. the icvc feature allows the reagent probe to dive into the reagent cassette and confirm the reagent level in the bottles. this ensures.
  • Action
    March 17, 2014 all consignees will be notified by Urgent Medical Device Correction sent via UPS Ground (receipt required). The notice identified the issue, root cause, affected assays with clinical significance. Consignees were instructed to follow the steps listed in the Urgent Medical Device Correction to correctly activate the ICVC and verify the correction. If your system is not connected to the Internet through the cobas link, and you do not have the option to run the affected reagents on an alternate system (i.e., cobas c 311 or cobas c 501 analyzer), please contact the Roche Support Network Customer Support Center at 1-800-428-2336 to have an update scheduled via a Roche Field Representative. If your system is connected to the Internet through the cobas link, follow the steps below: " Remove all reagent cobas c packs on board your cobas c 502 module for the assays listed on pages 1-2. " Dispose of these reagent cobas c packs according to your local waste management ordinances. " Load new cobas c packs for the affected assays, and visually verify the ICVC is performed. " Complete the attached fax form (5326-00-0314) and fax it to 1-888-276-6166. " Please consult with the physician or pathologist at your facility to determine specific clinical implications for your patients. " File this Urgent Medical Device Correction (UMDC) for future reference.

Device

Device Recall Cobas c8000 Modular Analyzer Series Cobasc502
  • Model / Serial
    not applicable
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    USA Nationwide Distribution including San Juan PR
  • Product Description
    Cobas c8000 Modular Analyzer Series Cobas c502, Part Number 5964067001, a clinical chemistry analyzer 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