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U.S. Department of Health and Human Services

Class 3 Device Recall ANA Flurescent Test System/Colorzyme Test System

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  Class 3 Device Recall ANA Flurescent Test System/Colorzyme Test System see related information
Date Initiated by Firm December 04, 2008
Date Posted April 06, 2009
Recall Status1 Terminated 3 on November 10, 2009
Recall Number Z-1044-2009
Recall Event ID 50518
510(K)Number K803276  K833148  
Product Classification ANA Flurescent Test System/Colorzyme Test System - Product Code DHN
Product ANA Fluorescent Test System and ANA Colorzyme Test System, Sub assembly catalog number SA 2013, Kit Catalog Numbers, 2000, 2002, 2003, 2004, 2005, 2100, 2200, 4000, 4200, 8024.1, and 8060, manufactured by Immuno Concepts N.A. Ltd, Sacramento, CA.


The device is used in the screening and titration of circulating antinuclear antibodies by means of an immunofluoresence test. Products are to be used as an aid in the detection of antibodies associated with systemic rheumatic disease.
Code Information Sub Assembly Lot Numbers: 0823200, 0823201, and 0825500 and Kit Lot Numbers: 826305, 0827311, 0828107, 0828108, 0828109, 0830914, 0831607, 0831606, 0829719, 0827315, 0827301, 0829413, 0829512, 0826905, 0828114, 0828804, 0829414, 0829721, 0830300, 0828307 and 0829513.
Recalling Firm/
Manufacturer		 Immuno Concepts Inc
9779 Business Park Dr Ste D
Sacramento CA 95827-1715
For Additional Information Contact
916-363-2649
Manufacturer Reason
for Recall		 Samples can occasionally run out of the wells and cross contaminate adjacent wells.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action The firm notified customers via a "Notice of Market Withdrawal" letter, e-mail and telephone. The letter described the problem and instructed customers to removed affected product from their inventory, complete the attached form and return it via fax to Immuno Concepts, Inc. at 916-363-2843. The firm will issue replacements as requested. Direct questions to Immuno Concepts, Inc. at 916-363-2649.
Quantity in Commerce 378 kits
Distribution Worldwide Distribution, USA (NC, WI, MS, MD, IL, GA, CA, MI and Puerto Rico) and countries of Sweden, Mexico, Spain and Denmark.
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 = DHN and Original Applicant = IMMUNO CONCEPTS, INC.
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