Class 3 Device Recall Architect AntiHBs Reagent

• Date Initiated by Firm: November 05, 2003
• Date Posted: December 11, 2003
• Recall Status: Terminated on July 20, 2004
• Recall Number: Z-0209-04
• Recall Event ID: 27667
• Product Classification: Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm) - Product Code LOM
• Product: Architect Anti-HBs Reagent Kit; list 7C18-25, 100 tests and list 7C18-20, 4 x 100 tests; Abbott Diagnostics, a Division of Abbott Laboratories, Abbott Park, IL 60064
• Code Information: List 7C18-20, 4 x 100 test kit, lots 07779M300, exp 06/19/2004 and 95551M300, exp 01/26/2004; and list 7C18-25, 100 test kit, lot 07779M301, exp 06/19/2004
• Recalling Firm/ Manufacturer: Abbott Laboratories HPD/ADD/GPRD; 100/200 Abbott Park Road; Abbott Park IL 60064
• Manufacturer Reason for Recall: Aspiration errors in the conjugate component due to microbial contamination of the conjugate.
• FDA Determined Cause: Other
• Action: Abbott affiliates in Canada, Germany, Australia, New Zealand, England and Japan were e-mailed copies of the recall letter on 11/5/03 for translation where needed and dissemination to their accounts receiving the suspect lots. The end users were advised of the aspiration errors in the conjugate component and were instructed to discontinue use and destroy any of the affected lots remaining.
• Quantity in Commerce: 2,244 kits
• Distribution: Canada, Japan, Australia, New Zealand, Germany and England
• 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.