Events

Recall of Device Recall Abbott AxSYM Cancer Assay Disk Version 5.0

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
    51275
  • Event Risk Class
    Class 2
  • Event Number
    Z-2222-2009
  • Event Initiated Date
    2009-02-20
  • Event Date Posted
    2009-09-18
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-08-23
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=79570
  • 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
    Kit, test,alpha-fetoprotein for testicular cancer - Product Code LOJ
  • Reason
    The axsym cancer assay disk (ln 3d50-05 version 5.0) contains an axsym afp assay file where the low concentration flag for the afp 1:101 automated dilution protocol the instrument to report results between 0 ng/ml and 0.4 ng/ml (40.4 ng/ml accounting for the 1:101 dilution). the sensitivity of the assay is 0.4 ng/ml.
  • Action
    Abbott sent "Product Correction Immediate Action Required" letters dated February 2, 2009 to all AxSYM AFP customers. Customers were requested to install the updated version of the AxSYM AFP assay using version 6.0 of the AxSYM Cancer Assay Disk provided with the letter and to retain a copy of this communication for their records. Any questions regarding the letter were directed to Customer Service at 1-877-4ABBOTT.

Device

Device Recall Abbott AxSYM Cancer Assay Disk Version 5.0
  • Model / Serial
    List Number 3D50-05, version 5.0
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- United States (including Puerto Rico), Australia, Bahamas, Barbados, Bermuda, Brazil, Canada, Cayman Islands, Chile, Columbia, Costa Rica, Curacao (Neth Ant), Dominican Republic, Germany, Guatemala, Hong Kong, Jamaica, Japan, Mexico, New Zealand, Peru, Singapore, South Korea, Taiwan, Thailand, Trinidad and Tobago, Turks and Caicos and Venezuela.
  • Product Description
    Abbott AxSYM Cancer Assay Disk Version 5.0, for in vitro diagnostic use with the AxSYM System; Abbott Laboratories, Abbott Park, IL 60064; List Number 3D50-05. || AxSYM AFP is a Microparticle Enzyme Immunoassay (MEIA) for the quantitative determination of alpha-fetoprotein (AFP).
  • 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