Events

Recall of Device Recall TDx/TDxFLx Cortisol Reagent Pack

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Abbott Laboratories HPD/ADD/GPRD.

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
    28342
  • Event Risk Class
    Class 3
  • Event Number
    Z-0723-04
  • Event Initiated Date
    2004-02-16
  • Event Date Posted
    2004-07-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-07-26
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=31623
  • 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
    Fluorometric, Cortisol - Product Code JFT
  • Reason
    The package inserts contain incorrect control values for the urinary free cortisol extraction procedure.
  • Action
    Field Correction recall by Important Product Information letter dated 2/16/04, sent via e-mail to the Abbott international subsidiaries on the same date for notification of all of their accounts receiving the Cortisol reagents and X Systems Cortisol controls since March 2002. The accounts were informed of the incorrect values for the Cortisol controls, when using the urinary free cortisol extraction procedure, listed in the package inserts of the reagent kits as well as the controls. The letters contained a table listing the incorrect values and the correct values for each of the products, and the users were instructed to use the corrected values as provided in the letter.

Device

Device Recall TDx/TDxFLx Cortisol Reagent Pack
  • Model / Serial
    list 9116-65, lots 04111M200, 10239M200, 10060M200, 10060M201
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    There was no domestic distribution. The product was distributed internationally through Abbott subsidiaries in Canada, United Kingdom, Japan, Singapore, Hong Kong, Korea, Australia, New Zealand, Honduras, Costa Rica, Panama, Dominican Republic, Germany and Pakistan.
  • Product Description
    TDx/TDxFLx Cortisol Reagent Pack, list 9116-65; Abbott Laboratories, Diagnostics Division, Abbott Park, IL 60064
  • Manufacturer
    Abbott Laboratories HPD/ADD/GPRD

Manufacturer

Abbott Laboratories HPD/ADD/GPRD
  • Manufacturer Address
    Abbott Laboratories HPD/ADD/GPRD, 100/200 Abbott Park Road, Abbott Park IL 60064
  • Source
    USFDA