Class 2 Device Recall

• Date Initiated by Firm: September 18, 2003
• Date Posted: November 06, 2003
• Recall Status: Terminated on March 30, 2004
• Recall Number: Z-0096-04
• Recall Event ID: 27432
• 510(K)Number: K011213 K014034 K023049 K965240
• Product Classification: Calculator/Data Processing Module, For Clinical Use - Product Code JQP
• Product: Synchron CX Systems version 4.0 Operating Software used in Synchron LX20 Systems, Synchron LX20 Pro Systems, Synchron LXi Systems.
• Code Information: All those with version 4.0 operating software.
• Recalling Firm/ Manufacturer: Beckman Coulter Inc; 200 South Kraemer Blvd; Brea CA 92821
• For Additional Information Contact: Kathleen Jaker; 714-961-3666
• Manufacturer Reason for Recall: Sample wheel may home to the wrong position.
• FDA Determined Cause: Other
• Action: Recall is accomplished by telephone and by letter. Telephone calls were made by 9/24/2003. All customers have been notified by telephone.
• Quantity in Commerce: 154
• Distribution: Nationwide and Canada
• 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 = JQP; 510(K)s with Product Code = JQP