Events

Recall of Eon 300 system

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by ELITech Clinical Systems SAS.

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
    72322
  • Event Risk Class
    Class 2
  • Event Number
    Z-0215-2016
  • Event Initiated Date
    2015-09-22
  • Event Date Posted
    2015-11-05
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-03-04
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=140617
  • 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
    Glucose oxidase, glucose - Product Code CGA
  • Reason
    Elitech clinical systems reagents based on trinder reaction used on the eon 300 instrument system are recalled due to potential drug interference. no complaints were received.
  • Action
    The firm sent recall letters or Technical Bulletins to US consignees on 9/22/15 via registered mail. Technical Bulletin #1022 (for EON 100 users) Technical Bulletin #2008 (for EON 300 users) Technical Bulletin #5064 (for ENVOY users) Technical Bulletin #3009 (for Selectra users) ELITechGroup is not requesting return of the affected product. The method sheets and package inserts will be updated with the new interference claims. When available, the revised labeling will be provided to the customer for customer's use until the new IFU is included in the product packaging. Consignees are requested to return the Confirmation of Receipt form back to the firm by FAX to 401-642-9001 or send email to customercare@elitechgroup.com or send via US Post: Vital Diagnostics, 27 Wellington Rd., Lincoln, Rl. If you have any questions, please contact Vital Diagnostics Technical Support at 1-800-345-2822 or 855-ELITECH

Device

Eon 300 system
  • Model / Serial
    all lots
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Nationwide Distribution
  • Product Description
    Eon 300 system includes the following product reference numbers and names: || Reference no. 79345 Glucose (GPSL) || Reference no. 79450 Uric acid (AUVD) || Reference no. 79435 Triglycerides (TGML) || Reference no. 79295 Cholesterol (CHVD) || Reference no. 79301 Cholesterol HDL (HDLL) || Reference no. 79310 Cholesterol, LDL (LDLL)
  • Manufacturer
    ELITech Clinical Systems SAS

Manufacturer

ELITech Clinical Systems SAS
  • Manufacturer Address
    ELITech Clinical Systems SAS, Zone lndustrielle, SEES France
  • Source
    USFDA