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U.S. Department of Health and Human Services

Class 3 Device Recall AxSYM Digoxin II Reagent Pack.

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  Class 3 Device Recall AxSYM Digoxin II Reagent Pack. see related information
Date Initiated by Firm May 22, 2008
Date Posted November 21, 2008
Recall Status1 Terminated 3 on September 09, 2011
Recall Number Z-0297-2009
Recall Event ID 48628
510(K)Number K953718  
Product Classification Digoxin Enzyme Immunoassay - Product Code KXT
Product AxSYM Digoxin II Reagent Pack, Disk Version 1. (3D53-01 or 3D53-02)

The AxSYM Digoxin II assay is a Microparticle Enzyme Immunoassay (MEIA) for the quantitative measurement of digoxin, a cardiovascular drug, in serum or plasma. The measurements obtained are used in the treatment of digoxin overdose and monitoring levels of digoxin to ensure appropriate therapy.
Code Information Lot 61275Q100, exp. date: 09/09/08; Lot 58167Q100, exp. date: 08/30/08; Lot 56039Q101, exp. date: 07/13/08; and Lot 56039Q100, exp. date: 07/13/08.
Recalling Firm/
Manufacturer		 Abbott Diagnostic International, Ltd.
Carr # 2 Km 58.0
Cruce Davila
Barceloneta PR 00617-3009
For Additional Information Contact Saritza Rios
787-846-3500 Ext. 3352
Manufacturer Reason
for Recall		 AxSYM TDM/ Transplant Assay Disks 3D53-03 and higher do not contain the AxSYM Digoxin II Assay file. The instrument might require installation of the AxSYM Digoxin II assay file.
FDA Determined
Cause 2		 Software change control
Action A Product Information letter, dated May 22, 2008, was issued to customers. It requested that one of the following two actions be taken if the AxSYM Digoxin II assay file is not installed on your AxSYM instrument and you want to run the AxSYM Digoxin II assay. If you have one of the previously manufactured software disks listed, [AxSYM Digoxin II Assay Disk, LN 2C43-01, or higher; or AxSYM TDM/Transplant Assay Disk Version 1.0 (3D53-01) or Version 2.0 (3D53-02)], install the AxSYM Digoxin II assay file. Do not install any other assay file. If you do not have one of the assay disks listed, contact your local Customer Service representative to have this assay file installed or install the file from a previous version if you have it on hand.
Quantity in Commerce 9069 kits
Distribution Worldwide Distribution --- USA including states of AL, AZ, AR, CA, CT, FL, GA, IL, KS, MD, MA, MI, MN, MS, MO, NV, NJ, NY, ND, OK, OR, PA, RI, TX, VA, WA, Hawaii, and Puerto Rico, and countries of Canada, Mexico, Guatemala, Costa Rica, Venezuela, Colombia, Ecuador, Peru, Chile, Uruguay, Argentina, Puerto Rico, Germany, Japan, Singapore, Hong Kong, Taiwan, Thailand, South Korea, Australia, New Zealand, Curacao, and Panama.
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 = KXT and Original Applicant = ABBOTT LABORATORIES
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