Class 2 Device Recall

• Date Initiated by Firm: November 24, 2003
• Date Posted: December 18, 2003
• Recall Status: Terminated on January 25, 2012
• Recall Number: Z-0240-04
• Recall Event ID: 27822
• Product Classification: Urease And Glutamic Dehydrogenase, Urea Nitrogen - Product Code CDQ
• Product: AEROSET/ARCHITECT c8000 Urea Nitrogen Models: 7D75-01; 7D75-20; 7D75-30
• Code Information: All lots.
• FEI Number: 2018433
• Recalling Firm/ Manufacturer: Abbott Laboratories Diagnostic Div; 820 Mission St; South Pasadena CA 91030-3142
• For Additional Information Contact: Linda Morris; 972-518-6711
• Manufacturer Reason for Recall: False low results may occur with out error codes due to substrate depletion in samples with more than 220mg/dL BUN.
• FDA Determined Cause: Other
• Action: Firm sent letter to customers dated November 24,2003 which includes a new package insert to use with this reagent. Instructions were changed to correct low resulting situation. Subrecall was requested.
• Quantity in Commerce: All lots.
• Distribution: Nationwide and Mexico, Brazil, Germany, Singapore, Grand Cayman, Venezuela, Puerto Rico, Hong Kong, Australia, Columbia, Dominican Republic, China, Trinidad, Argentina, Canada, New Zealand, Bahamas
• 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.