Events

Recall of Device Recall AxSYM Drugs of Abuse/Toxicology Assay Disk Version 8.0

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

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
    46740
  • Event Risk Class
    Class 3
  • Event Number
    Z-1462-2008
  • Event Initiated Date
    2008-01-21
  • Event Date Posted
    2008-05-14
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-12-01
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=68116
  • 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
    Amphetamine test system - Product Code DKZ
  • Reason
    Error message: if the positive and negative interpretation cutoff parameters (116/117) are edited after installation of the revised assay file, vrtx error #0002 in task 40 is generated and the instrument locks up when it attempts to report an axsym amphetamine/methamphetamine ii patient result.
  • Action
    Consignees were sent a Product Correction-Immediate Action Required letter on 1/21/08. The letter provided users with the steps to take to temporarily correct the problem until the recalling firm is able to send a corrected assay file. Users were requested to return a customer reply letter acknowledging receipt of the letter. For additional information, contact 1-877-4ABBOTT.

Device

Device Recall AxSYM Drugs of Abuse/Toxicology Assay Disk Version 8.0
  • Model / Serial
    Lot Numbers: 59311P100 and 59312P100.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution including USA territory of Puerto Rico, and countries of Australia, Canada, Chile, Colombia, Germany, Mexico, New Zealand, South Korea, Taiwan, Thailand and Venezuela.
  • Product Description
    AxSYM Drugs of Abuse/Toxicology Assay Disk Version 8.0; List Number: 3D54-08; Abbott La boratories, Diagnostics Division, Abbott Park, IL 60064
  • Manufacturer
    Abbott Laboratories

Manufacturer

Abbott Laboratories
  • Manufacturer Address
    Abbott Laboratories, 100 Abbott Park Rd, Abbott Park IL 60064-3502
  • Manufacturer Parent Company (2017)
    Abbott Laboratories
  • Manufacturer comment
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    USFDA