Class 2 Device Recall

• Date Initiated by Firm: March 29, 2004
• Date Posted: July 20, 2004
• Recall Status: Terminated on September 07, 2004
• Recall Number: Z-0904-04
• Recall Event ID: 28851
• 510(K)Number: K023764
• Product Classification: Analyzer, Chemistry (Photometric, Discrete), For Clinical Use - Product Code JJE
• Product: UniCel Dxl 800 Access Immunoassay System, P/N 973100.
• Code Information: All software versions pior to version 1.4
• Recalling Firm/ Manufacturer: Beckman Coulter Inc; 200 S Kraemer Blvd; Brea CA 92822-6208
• For Additional Information Contact: Kathleen M. Jaker; 714-961-3666
• Manufacturer Reason for Recall: Software coding error may cause a fatal error message.
• FDA Determined Cause: Other
• Action: Each user will be contacted initially and then once more to ensure that the users have recieved the recall letter and have installed the new software included with the letter. Recall letters were sent March 29, 2003.
• Quantity in Commerce: 73
• 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 = JJE