Events

Recall of Device Recall TDx/TDxFLX

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Abbott Health Products, 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
    Recall
  • Event ID
    27843
  • Event Risk Class
    Class 2
  • Event Number
    Z-0325-04
  • Event Initiated Date
    2003-11-17
  • Event Date Posted
    2004-01-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-11-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=30657
  • 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
    Radioimmunoassay, Tricyclic Antidepressant Drugs - Product Code LFG
  • Reason
    Drug product cross reacts with the tricyclic antidepressants (tca) assay.
  • Action
    The Important Information Letter dated 11/17/03 was mailed to all ADx, TDx/TDxFL and AxSYM TCA reagent customers. The letters were sent to customers by Federal express Priority mail. The letter recommended contacting all customers who have received the reagents within the last 15 months.

Device

Device Recall TDx/TDxFLX
  • Model / Serial
    Product List number: 9681-60
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distribution was nationwide.
  • Product Description
    TDx/TDxFLx Tricyclic Antidepressants Reagent. Distributed under the following label: TDx/TDxFLx Antidepressants Reagents, Abbott Laboratories USA, North Chicago, IL 60064.
  • Manufacturer
    Abbott Health Products, Inc.

Manufacturer

Abbott Health Products, Inc.
  • Manufacturer Address
    Abbott Health Products, Inc., Hwy 2 Km 58.0, Barceloneta PR 00617
  • Source
    USFDA