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Class 2 Device Recall |
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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/ Manufacturer |
Abbott Laboratories Diagnostic Div 820 Mission St South Pasadena CA 91030-3142
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For Additional Information Contact |
Linda Morris 972-518-6711
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Manufacturer Reason for Recall |
Low results due to contaminant.
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FDA Determined Cause 2 |
Other |
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 |
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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.
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