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U.S. Department of Health and Human Services

Class 3 Device Recall AxSYM Drugs of Abuse/Toxicology Assay Disk Version 8.0

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 Class 3 Device Recall AxSYM Drugs of Abuse/Toxicology Assay Disk Version 8.0see related information
Date Initiated by FirmJanuary 21, 2008
Date PostedMay 14, 2008
Recall Status1 Terminated 3 on December 01, 2009
Recall NumberZ-1462-2008
Recall Event ID 46740
510(K)NumberK953115 
Product Classification Amphetamine test system - Product Code DKZ
ProductAxSYM Drugs of Abuse/Toxicology Assay Disk Version 8.0; List Number: 3D54-08; Abbott La boratories, Diagnostics Division, Abbott Park, IL 60064
Code Information Lot Numbers: 59311P100 and 59312P100.
Recalling Firm/
Manufacturer		 Abbott Laboratories
100 Abbott Park Rd
Abbott Park IL 60064-3502
For Additional Information ContactAbbott Customer Support
877-422-2688
Manufacturer Reason
for Recall		Error Message: If the Positive and Negative Interpretation Cutoff parameters (116/117) are edited after installation of the revised assay file, VRTX error #0002 in Task 40 is generated and the instrument locks up when it attempts to report an AxSYM Amphetamine/Methamphetamine II patient result.
FDA Determined
Cause 2		Software change control
ActionConsignees were sent a Product Correction-Immediate Action Required letter on 1/21/08. The letter provided users with the steps to take to temporarily correct the problem until the recalling firm is able to send a corrected assay file. Users were requested to return a customer reply letter acknowledging receipt of the letter. For additional information, contact 1-877-4ABBOTT.
Quantity in Commerce1,270 disks
DistributionWorldwide Distribution including USA territory of Puerto Rico, and countries of Australia, Canada, Chile, Colombia, Germany, Mexico, New Zealand, South Korea, Taiwan, Thailand and Venezuela.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = DKZ
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