Class 2 Device Recall AXSYM System

• Date Initiated by Firm: October 29, 2003
• Date Posted: December 25, 2003
• Recall Status: Terminated on November 13, 2007
• Recall Number: Z-0274-04
• Recall Event ID: 27730
• 510(K)Number: K974651
• Product Classification: Analyzer, Chemistry (Photometric, Discrete), For Clinical Use - Product Code JJE
• Product: The AXSYM System, Clinical Chemistry Analyzer, Manufactured by Abbott Laboratories, Irving, Texas
• Code Information: Lot Number: 07A83-01, 07A083-03, 07A83-95, 07A83-98; All serial numbers
• Recalling Firm/ Manufacturer: Abbott Laboratories, Inc; 1921 Hurd Drive; PO Box 152020; Irving TX 75038
• Manufacturer Reason for Recall: Potential for a contaminated Reaction Vessel (RV) or previously used RV to remain on the AxSYM System.
• FDA Determined Cause: Other
• Action: All current US AxSYM System consignees will receive the Device Correction letter via direct mailing. A 100% effectiveness check will be performed against AxSYM consignees not responding, via Customer Reply Form. An electronic copy of the Device Correction letter and communication package will be provided to all Abbott Affilities worldwide for communicating with their customers.
• Quantity in Commerce: 17,850
• Distribution: Worldwide
• 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 = JJE