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
    25220
  • Event Risk Class
    Class 2
  • Event Number
    Z-0691-03
  • Event Initiated Date
    2002-12-11
  • Event Date Posted
    2003-03-29
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-06-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=25409
  • 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 91
  • Reason
    Unexpected false positive tca results.
  • Action
    A Device Correction letter was mail to all customers on 12 /11/02. The letter explained the reason for the recall and provided specific instructions.

Device

Device Recall TDx/TDxFLx
  • Model / Serial
    List no. 9681-60
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Distribution
    Distribution was nationwide, VA/DOD accounts. The foreign distribution was as follows: Mexico, Venezuela, Colombia, Chile, Uruguay, Argentina, Brazil, Canada, England, Japan, Singapore, Hong Kong, Taiwan, Thailand, Costa Rica, New Zealand and Panama
  • Product Description
    TDx/TDxFLx || TDx/TDxFLX Tricyclic Antidepressant Reagent || Distributed under the following label: || TDx/TDxFLX, 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