Class 2 Device Recall ARCHITECT c8000

• Date Initiated by Firm: November 17, 2003
• Date Posted: December 24, 2003
• Recall Status: Terminated on October 28, 2004
• Recall Number: Z-0263-04
• Recall Event ID: 27731
• 510(K)Number: K980367
• Product Classification: Calculator/Data Processing Module, For Clinical Use - Product Code JQP
• Product: The ARCHITECT c8000, Clinical Chemistry Analyzer, Manufactured by Abbott Laboratories, Irving, Texas
• Code Information: List Number 1G06-01, all serial numbers
• Recalling Firm/ Manufacturer: Abbott Laboratories, Inc; 1921 Hurd Drive; PO Box 152020; Irving TX 75015-2020
• Manufacturer Reason for Recall: Sample Identification (SID) numbers of a bar coded sample may be truncated, or shortened, after being scanned by the bar code reader (e.g. an actual SID of 123456 is shortened to 1234)
• FDA Determined Cause: Other
• Action: The firm plans to distribute a Product Information Letter and an updated ARCHITECT i System Operations Manufal Addendum to all US ARCHITECT customers. An electronic version of these documents was sent to all Abbott affilities worldwide for distribution to their ARCHITECT customers.
• Quantity in Commerce: 148
• Distribution: Mexico, Puerto Rico, Japan, Taiwan, Australia, Colombia, Cananda, Hong Kong, New Zealand, Netherlands, Singapore, Germany, Grand Cayman, Korea, Chile, Thailand, TX, PA, SC, CA, IN.
• 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 = JQP