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U.S. Department of Health and Human Services

Class 3 Device Recall Cholesterol Reagent

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  Class 3 Device Recall Cholesterol Reagent see related information
Date Initiated by Firm November 07, 2002
Date Posted December 31, 2002
Recall Status1 Terminated 3 on May 15, 2012
Recall Number Z-0404-03
Recall Event ID 25081
510(K)Number K880237  
Product Classification Enzymatic Esterase--Oxidase, Cholesterol - Product Code CHH
Product Elan Diagnostics CHO ATAC Cholesterol Reagent Kit
Product Number: 516-250
Code Information Lot Number: 2030000 Exp.Date: 11/30/03
Recalling Firm/
Manufacturer		 Elan Diagnostics, Inc.
2 Thurber Boulevard
Smithfield RI 02917
For Additional Information Contact Peter J. Sacchetti
417-401-233 Ext. 3526
Manufacturer Reason
for Recall		 Potential for reporting lower than actual HDL (cholesterol) results due to low QC Recovery
FDA Determined
Cause 2		 Other
Action The firm notified Distributors by telephone on 11/4/02 and end-users by Certified Mail on 11/4/02. Distributors and End-users are requested to dispose of product and return label for replacement product.
Quantity in Commerce 170 Kits
Distribution Nationwide
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 = CHH and Original Applicant = TECH-NEAL SCIENTIFIC, INC.
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