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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 Nitrogensee related information
Date Initiated by FirmOctober 03, 2011
Date PostedNovember 16, 2011
Recall Status1 Terminated 3 on May 11, 2012
Recall NumberZ-0189-2012
Recall Event ID 60059
510(K)NumberK981918 
Product Classification Urease and glutamic dehydrogenase, urea nitrogen - Product Code CDQ
ProductClinical 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 ContactMark 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
ActionThe 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 Commerce5704 units of Urea Nitrogen
DistributionWorldwide Distribution.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = CDQ
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