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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 February 26, 2004
Recall Status1 Terminated 3 on February 07, 2012
Recall Number Z-0550-04
Recall Event ID 27820
Product Clinical Chemistry Urea Nitrogen
Code Information Lots: 05073HW00 04022Hw00 03041HW00
Recalling Firm/
Abbott Laboratories Diagnostic Div
820 Mission St
South Pasadena CA 91030-3142
For Additional Information Contact Linda Morris
Manufacturer Reason
for Recall
Low results due to contaminant.
FDA Determined
Cause 2
Action Each domestic customer will receive the recall letter by direct mailing. Foreign affiliates will be responsible for distributing letters to thier customers. Letters were sent 11/24/2003. A reply form was enclosed.
Quantity in Commerce 568
Distribution Nationwide, Mexico, Argentina, Germany, Australia, Venezuela, Puerto Rico, Singapore, New Zealand, Columbia, Canada, Hong Kong, Grand Cayman

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.