Class 2 Device Recall

• Date Initiated by Firm: December 16, 2002
• Date Posted: February 05, 2003
• Recall Status: Terminated on December 01, 2004
• Recall Number: Z-0545-03
• Recall Event ID: 25359
• 510(K)Number: K965240 K014034 K011213 K014034
• Product Classification: Electrode, Ion Specific, Sodium - Product Code JGS
• Product: SYNCHRON LX20 AND LX20 Pro
• Code Information: All serial numbers.
• Recalling Firm/ Manufacturer: Beckman Coulter Inc; 200 South Kraemer Blvd W 337; Brea CA 92822
• For Additional Information Contact: Lynne McBride; 714-993-5321
• Manufacturer Reason for Recall: The disk that controls the home position of the sample wheel comes loose preventing a proper home sequence.
• FDA Determined Cause: Other
• Action: Firm will inspect instruments for failure conditions and fix the problem.
• Quantity in Commerce: 1001
• Distribution: Canada and USA.
• 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 = JGS and Original Applicant = BECKMAN COULTER, INC.; 510(K)s with Product Code = JGS and Original Applicant = BECKMAN INSTRUMENTS, INC.