Class 2 Device Recall ARCHITECT CA 199 Reagent Kit

• Date Initiated by Firm: March 23, 2004
• Date Posted: July 20, 2004
• Recall Status: Terminated on April 26, 2005
• Recall Number: Z-0781-04
• Recall Event ID: 28641
• Product Classification: System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer - Product Code NIG
• Product: ARCHITECT CA 19-9 Reagent Kit, list 6C04-20 (1 x 100 tests) and 6C04-25 (4 x 100 tests), Abbott laboratories, Abbott Park, IL 60064 U.S.A.
• Code Information: lot numbers 07747M100 and 07747M101
• FEI Number: 1415939
• Recalling Firm/ Manufacturer: Abbott Laboratories HPD/ADD/GPRD; 100/200 Abbott Park Road; Abbott Park IL 60064
• Manufacturer Reason for Recall: The reagent lots may produce patient results that are lower than expected when compared to other lots of in-date reagents.
• FDA Determined Cause: Other
• Action: Abbott international affiliates were notified of the recall by e-mail on 3/23/04, and requested to notify their customers.
• Quantity in Commerce: 1,987 kits
• Distribution: Canada, Australia, Germany and Japan
• 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.