Class 2 Device Recall

• Date Initiated by Firm: March 18, 2004
• Date Posted: July 20, 2004
• Recall Status: Terminated on February 10, 2012
• Recall Number: Z-0769-04
• Recall Event ID: 28627
• Product Classification: Acid, Uric, Uricase (U.V.) - Product Code CDO
• Product: Clinical Chemistry Uric Acid; LN 7D76-20
• Code Information: Lot number: 95015HW00
• FEI Number: 2018433
• Recalling Firm/ Manufacturer: Abbott Laboratories Diagnostic Div; 820 Mission St; South Pasadena CA 91030-3142
• For Additional Information Contact: Mark Littlefield; 972-518-6062
• Manufacturer Reason for Recall: Unacceptable upward drift of results in control runs within 24 hour period.
• FDA Determined Cause: Other
• Action: Firm sent recall letters 3/18/2004 suggesting destruction and/or running QC tests every eight hours instead of every 24 hours as is in labeling.
• Quantity in Commerce: 796 kits.
• Distribution: Nationwide and Mexico, Equador, Puerto Rico, Hong Kong, Bahamas, Venezuela, Argentina, Canada, New Zealand, Columbia, Brazil, England, Trinidad.
• 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.