Events

Recall of Device Recall Roche Hitachi K electrode

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
    35873
  • Event Risk Class
    Class 3
  • Event Number
    Z-1447-06
  • Event Initiated Date
    2006-07-21
  • Event Date Posted
    2006-08-29
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-11-01
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=47067
  • 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
    Potassium electrode - Product Code CEM
  • Reason
    Expired product (dated 2006.06) was shipped as replacement for recalled product.
  • Action
    Consignees were notified by phone and sent a recall letter dated 7/21/06 via fax, which instructed them to discontinue use of these lots of product and to discard them.

Device

Device Recall Roche Hitachi K electrode
  • Model / Serial
    Lots I90, I93 and I95 (alpha I and two digits)
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide.
  • Product Description
    Roche/Hitachi K Electrode, a potassium electrode for use with the Roche/Hitachi models 717,747, 902, 911,912, 917, Modular and Cobas c 501clinical chemistry analyzers; Roche Catalog/Part Number 10825441001/ US # 722-4402.
  • Manufacturer
    Roche Diagnostics Corp.

Manufacturer

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