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U.S. Department of Health and Human Services

Class 2 Device Recall Abbott AxSYM Matrix Cells

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  Class 2 Device Recall Abbott AxSYM Matrix Cells see related information
Date Initiated by Firm September 08, 2006
Date Posted November 17, 2006
Recall Status1 Terminated 3 on January 24, 2012
Recall Number Z-0117-2007
Recall Event ID 36417
510(K)Number K974651  K041811  
Product Classification Matrix Cells - Product Code JJE
Product Abbott AxSYM Matrix Cells--Product List No: 8A73-02, sold in boxes of 100
Code Information Lot # 37618Q100 Expiration Date 12/05/2006
Recalling Firm/
Abbott Diagnostic International, Ltd.
Carr 2 Km 58.0
Cruce Davila
Barceloneta PR 00617-3009
Manufacturer Reason
for Recall
Increase in complaints regarding controls out of range, calibration errors, and discrepant patient results with the AxSYM Troponin-I ADV assay.
FDA Determined
Cause 2
Quantity in Commerce 2,355 boxes of 100
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
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = JJE and Original Applicant = ABBOTT LABORATORIES