Events

Recall of TDx/TDxFLx Opiates Reagent, Product list number: 9673-60

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
    29289
  • Event Risk Class
    Class 2
  • Event Number
    Z-1229-04
  • Event Initiated Date
    2004-05-28
  • Event Date Posted
    2004-07-28
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-09-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=33478
  • 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
    Enzyme Immunoassay, Opiates - Product Code DJG
  • Reason
    Abbott diagnostics division has found that the oxymorphone cross-reactivity information in the 'specific performance characteristics' section of the tdx/tdxflx opiates reagent package insert (commodity number 32-2087/r5) does not match the current product performance.
  • Action
    A Device Correction Letter dated 5/28/04 was mailed to all customers. The letter explained the reason for the recall and provided specific instructions.

Device

TDx/TDxFLx Opiates Reagent, Product list number: 9673-60

Manufacturer

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