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U.S. Department of Health and Human Services

Class 2 Device Recall Abbott Clinical Chemistry Urea Nitrogen

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  Class 2 Device Recall Abbott Clinical Chemistry Urea Nitrogen see related information
Date Initiated by Firm October 03, 2011
Date Posted November 16, 2011
Recall Status1 Terminated 3 on May 11, 2012
Recall Number Z-0189-2012
Recall Event ID 60059
510(K)Number k981918  
Product Classification Urease and glutamic dehydrogenase, urea nitrogen - Product Code CDQ
Product Clinical Chemistry Urea Nitrogen List Number 7D75-21 and 7D75-31 used for the Quantitation of urea nitrogen in human serum, plasma, and urine.
Code Information Urea Nitrogen 7D75-21 (lot 97642UN11) and Urea Nitrogen 7D75-31 (lot 97668UN11)
Recalling Firm/
Manufacturer		 Abbott Laboratories, Inc
1921 Hurd Drive
PO Box 152020
Irving TX 75038-4313
For Additional Information Contact Mark Littlefield
972-518-6000
Manufacturer Reason
for Recall		 The reagents are being recalled due to particulate matter in some of the reagent cartridges. The particulate matter has been identified as Aureobasidium fungus species.
FDA Determined
Cause 2		 Process control
Action The firm decided to recall and they sent a Product Recall Letter to their customers on 10/03/2011. Questions regarding the letter should be directed to Customer Service at 1-877-4ABBOTT for US customers, and customers outside of the US should contact their local area Customer Service. Customers should determine if you have any remaining inventory. Please discontinue and destroy any remaining inventory of these lots. Order alternative lots of Clinical Chemistry Urea Nitrogen. Complete and return the enclosed Customer Reply form.
Quantity in Commerce 5704 units of Urea Nitrogen
Distribution Worldwide Distribution.
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.
510(K) Database 510(K)s with Product Code = CDQ and Original Applicant = ABBOTT LABORATORIES
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