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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 November 24, 2003
Date Posted December 18, 2003
Recall Status1 Terminated 3 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.
Recalling Firm/
Abbott Laboratories Diagnostic Div
820 Mission St
South Pasadena CA 91030-3142
For Additional Information Contact Linda Morris
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 2
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.