Class 3 Device Recall

• Date Initiated by Firm: June 18, 2003
• Date Posted: August 21, 2003
• Recall Status: Terminated on April 20, 2004
• Recall Number: Z-1148-03
• Recall Event ID: 26726
• 510(K)Number: K922823
• Product Classification: Enzyme Immunoassay, Theophylline - Product Code KLS
• Product: Access Immunoassay System Technical Update 03.1, Part number 387851, Software version 3.29
• Code Information: Software version 3.29
• FEI Number: 2050012
• Recalling Firm/ Manufacturer: Beckman Coulter Inc; 200 South Kraemer Blvd W 337; Brea CA 92822
• For Additional Information Contact: Kathleen M. Jaker; 714-961-3666
• Manufacturer Reason for Recall: Defective software media distributed with upgrade software may cause installation failure and systems lock.
• FDA Determined Cause: Other
• Action: Calls were made to customers between 6/18/2003 and 7/3/2003 to possibly intercept an installation attempt and replace the given disk with unaffected media.
• Quantity in Commerce: 1615
• Distribution: United States only, 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 = KLS