Class 2 Device Recall ARCHITECT c8000 System

• Date Initiated by Firm: September 14, 2005
• Date Posted: October 06, 2005
• Recall Status: Terminated on September 25, 2007
• Recall Number: Z-0010-06
• Recall Event ID: 33460
• 510(K)Number: K980367
• Product Classification: Analyzer, Chemistry (Photometric, Discrete), For Clinical Use - Product Code JJE
• Product: ARCHITECT c8000 Analyzer System Processing Module, a fully automated, random access, clinical chemistry analyzer which utilizes spectrophotometry (monochromatic and bichromatic modes of measurement) for photometric based determinations.
• Code Information: All serial numbers, List number 1G06-01
• Recalling Firm/ Manufacturer: Abbott Laboratories, Inc; 1921 Hurd Drive; PO Box 152020; Irving TX 75038
• Manufacturer Reason for Recall: Software deficiency causing potential shift in absorbance readings for test results.
• FDA Determined Cause: Other
• Action: Firm sent device correction letter to consignees on 9/14/2005.
• Quantity in Commerce: 1,107 units
• Distribution: Nationwide and 21 foreign countries. Foreign countries: Mexico, Guatemala, Venezuela, Colombia, Ecuador, Chile, Uruguay, Argentina, Brazil, Puerto Rico, Jamaica, San Salvador, Canada, Germany, Singapore, China, Thailand, Australia, New Zealand, Panama, and Grand Cayman
• 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