Events

Recall of Device Recall TDx/TDxFLx REA Ethanol

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
    27971
  • Event Risk Class
    Class 3
  • Event Number
    Z-0508-04
  • Event Initiated Date
    2003-12-05
  • Event Date Posted
    2004-02-04
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-04-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=30825
  • 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 and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel data.
  • Extra notes in the data
    unknown device name - Product Code DIC--
  • Reason
    The reagent package inserts for the products contain incorrect information in the specific performance characteristics section. accuracy by correlation table.
  • Action
    Field Correction recall by Important Product Information letter dated 12/5/03, sent via Federal Express Priority on the same date to all customers receiving the affected reagents. The accounts were informed of the incorrect values for the Specific Performance Characteristics listed in the package inserts of the reagent kits. The letters contained a table listing the incorrect values and the correct values for each of the products, and the users were instructed to replace their product inserts with the enclosed revised package inserts for all product specific reagent kits in their laboratory.

Device

Device Recall TDx/TDxFLx REA Ethanol
  • Model / Serial
    All lots with insert version 69-5787/R4. The corrected insert is version 34-2778/R5.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide and internationally through Abbott subsidiaries in Mexico, Guatemala, Colombia, Chile, Argentina, Brazil, Puerto Rico, San Salvador, Canada, England, Japan, Singapore, Hong Kong, Taiwan, Thailand, Korea, Australia, New Zealand, Honduras, Costa Rica, Bahamas, Panama, Dominican Republic and China.
  • Product Description
    TDx/TDxFLx REA Ethanol, list 9545-60; 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