Recall of Abbott AxSYM Matrix Cells

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

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
  • Event ID
  • Event Risk Class
    Class 2
  • Event Number
  • Event Initiated Date
  • Event Date Posted
  • Event Status
  • Event Country
  • Event Terminated Date
  • Event Source
  • Event Source URL
  • 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
    Matrix Cells - Product Code JJE
  • Reason
    Increase in complaints regarding controls out of range, calibration errors, and discrepant patient results with the axsym troponin-i adv assay.


  • Model / Serial
    Lot # 37618Q100 Expiration Date 12/05/2006
  • Product Classification
  • Device Class
  • Implanted device?
  • Distribution
    Nationwide including the states of AL, AK, AZ, CA, CT, CO, DE, FL, GA, ID, IL, IA, IN, KS, KY, LA, MA, ME, MI, MS, MN, MT, MO, NM, NJ, NY, NV, OH, OK, PA, RI, SC, TN, TX, UT, VA, WA, WI, Hawaii and Puerto Rico
  • Product Description
    Abbott AxSYM Matrix Cells--Product List No: 8A73-02, sold in boxes of 100
  • Manufacturer


  • Manufacturer Address
    Abbott Diagnostic International, Ltd., Carr 2 Km 58.0, Cruce Davila, Barceloneta PR 00617-3009
  • Source