Class 2 Device Recall ARCHITECT c8000 Asay Disk, Version 5.00

• Date Initiated by Firm: February 28, 2005
• Date Posted: October 06, 2005
• Recall Status: Terminated on November 03, 2005
• Recall Number: Z-0008-06
• Recall Event ID: 33432
• 510(K)Number: K980367
• Product Classification: Analyzer, Chemistry (Photometric, Discrete), For Clinical Use - Product Code JJE
• Product: ARCHITECT c800 for Conventional Units and for SI Units, Version 5.00.
• Code Information: List number 08G98-07 for Conventional Units; List number 04J62-07 for SI Units.
• Recalling Firm/ Manufacturer: Abbott Laboratories, Inc; 1921 Hurd Drive; PO Box 152020; Irving TX 75038
• Manufacturer Reason for Recall: Device has incorrect notation associated with therapeutic drug monitoring assays.
• FDA Determined Cause: Other
• Action: Firm sent device correction letters to consignees on 2/28/2005.
• Quantity in Commerce: 1,107 units worldwide
• Distribution: California, Louisiana, Massachusetts, North Carolina, Missouri, Oklahoma, Texas, Illinois, Minnesota, South Dakota, North Dakota and Arizona. Foreign countries: Mexico, Columbia, Chile, Canada, Germany, Singapore, China, Australia, and New Zealand
• 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 and Original Applicant = ABBOTT LABORATORIES