Class 3 Device Recall Cholesterol Reagent

• Date Initiated by Firm: November 07, 2002
• Date Posted: December 31, 2002
• Recall Status: Terminated 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: 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