Events

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
    Recall
  • Event ID
    36417
  • Event Risk Class
    Class 2
  • Event Number
    Z-0117-2007
  • Event Initiated Date
    2006-09-08
  • Event Date Posted
    2006-11-17
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-01-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=48621
  • 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.

Device

Abbott AxSYM Matrix Cells
  • Model / Serial
    Lot # 37618Q100 Expiration Date 12/05/2006
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • 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
    Abbott Diagnostic International, Ltd.

Manufacturer

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