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U.S. Department of Health and Human Services

Class 2 Device Recall Abbott AxSYM System Digoxin III Reagent Pack

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  Class 2 Device Recall Abbott AxSYM System Digoxin III Reagent Pack see related information
Date Initiated by Firm March 30, 2007
Date Posted August 29, 2007
Recall Status1 Terminated 3 on June 10, 2011
Recall Number Z-1202-2007
Recall Event ID 37904
510(K)Number K061249  
Product Classification in vitro diagnostic - Product Code KXT
Product Abbott AxSYM System Digoxin III Reagent Pack
Code Information Lot # 42740Q100 Exp Date: 05/11/07 Lot # 46181Q100 Exp Date: 08/10/07 Lot # 42722Q100 Exp Date: 05/11/07
Recalling Firm/
Manufacturer		 Abbott Diagnostic International, Ltd.
30 Bo Cruce Davila
Barceloneta PR 00617-3009
Manufacturer Reason
for Recall		 Customers are receiving error codes (1062, 1063, 1113, & 1118) when running patient samples on the AxSYM Digoxin III assay.
FDA Determined
Cause 2		 Other
Action On Abbott letterhead dated March 30, 2007 - The instructions are to provide a copy of the accompanying Product Correction Letter to the laboratory manager/supervisor responsible for AxSYM Digoxin II or AxSYM Digoxin III testing. The laboratory manager/supervisor should complete the information on the letter acknowledging receipt of the product Correction Letter and Fax the Customer Reply Form, prior April 12, 2007 to Fax number 1-800-777-0051.
Quantity in Commerce 2,579 kits
Distribution Worldwide, including USA, Puerto Rico, Canada, Uruguay, Germany, Japan, Hong Kong, South Korea, Australia, and New Zealand.
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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