Class 3 Device Recall ARCHITECT

• Date Initiated by Firm: June 10, 2004
• Date Posted: August 13, 2004
• Recall Status: Terminated on November 19, 2004
• Recall Number: Z-1341-04
• Recall Event ID: 29587
• 510(K)Number: K980367
• Product Classification: Electrode, Ion-Specific, Chloride - Product Code CGZ
• Product: ARCHITECT c8000 Processing Module; List Number 01G06-01. Manufactured by Toshiba Corporation, Medical Systems Division, Japan. Distributed by Abbott Laboratories Diagnostic Division, Irving, Texas
• Code Information: Serial numbers C800174 through C800346 and the following Serial numbers: C800072, C800122, C800131, and C800142
• Recalling Firm/ Manufacturer: Abbott Laboratories, Inc; 1921 Hurd Drive; PO Box 152020; Irving TX 75038
• Manufacturer Reason for Recall: Process change in the manufacturing of the AC/DC driver board used on the analyzer may result in one or more of the solid state relays to fail during use.
• FDA Determined Cause: Other
• Action: The firm initiated the recall by Technical Service Bulletin sent to affected customers. The AC/DC boards will be replaced on each analyzer by a firm representative.
• Quantity in Commerce: 171 units and 25 spare parts distributed
• Distribution: Product was distrbued nationwide and to the following foreign countries: Mexico, Australia, Germany, Hong Kong, Canada, Thailand, Grand Cayman, Chile, New Zealand, Columbia, Brazil, and Singapore.
• 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 = CGZ