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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm March 18, 2004
Date Posted July 20, 2004
Recall Status1 Terminated 3 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
Recalling Firm/
Abbott Laboratories Diagnostic Div
820 Mission St
South Pasadena CA 91030-3142
For Additional Information Contact Mark Littlefield
Manufacturer Reason
for Recall
Unacceptable upward drift of results in control runs within 24 hour period.
FDA Determined
Cause 2
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.