Class 3 Device Recall ARCHITECT i

• Date Initiated by Firm: January 27, 2003
• Date Posted: May 09, 2003
• Recall Status: Terminated on April 07, 2004
• Recall Number: Z-0795-03
• Recall Event ID: 25701
• Product Classification: Analyzer, Chemistry (Photometric, Discrete), For Clinical Use - Product Code JJE
• Product: ARCHITECT i System External Waste Pump
• Code Information: Product List Number 8C94-99, no lot numbers or codes
• Recalling Firm/ Manufacturer: Abbott Laboratories, Inc; 1921 Hurd Drive; PO Box 2020; Irving TX 75038
• Manufacturer Reason for Recall: External waste pump has metal edge around perimeter sharp enough to cause scratch or cut.
• FDA Determined Cause: Other
• Action: Firm sent 01/27/2003 letter to all consingees informing them of the issue. US Cutomer Reply form will be distributed with the customer letter.
• Quantity in Commerce: 1318 units
• Distribution: Nationwide and to the following foreign countries: Mexico, Chilie, Columbia, Dominican Republic, Hong Kong, Guatemala, Argentina, Canada, Australia, Venezuela, Brazil, Germany, New Zealand, Malaysia, Japan, Taiwan, Korea, Singapore, Thailand
• 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.