Recall of Device Recall Cholesterol Reagent

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Elan Diagnostics, 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
  • Event ID
  • Event Risk Class
    Class 3
  • Event Number
  • Event Initiated Date
  • Event Date Posted
  • Event Status
  • Event Country
  • Event Terminated Date
  • Event Source
  • Event Source URL
  • 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
    Enzymatic Esterase--Oxidase, Cholesterol - Product Code CHH
  • Reason
    Potential for reporting lower than actual hdl (cholesterol) results due to low qc recovery.
  • Action
    The firm notified Distributors by telephone on 11/4/02 and end-users by Certified Mail on 11/4/02. Distributors and End-users are requested to dispose of product and return label for replacement product.



  • Manufacturer Address
    Elan Diagnostics, Inc., 2 Thurber Boulevard, Smithfield RI 02917
  • Source