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U.S. Department of Health and Human Services

Class 2 Device Recall

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 Class 2 Device Recallsee related information
Date Initiated by FirmJuly 27, 2004
Date PostedAugust 17, 2004
Recall Status1 Terminated 3 on May 02, 2012
Recall NumberZ-1377-04
Recall Event ID 29684
510(K)NumberK981799 
Product Classification Alkaline Picrate, Colorimetry, Creatinine - Product Code CGX
ProductAbbott Clinical Chemistry AEROSET/ ARCHITECT c8000 Creatinine. List No. 7D64-20
Code Information Lot 14032HW00 Exp November 17, 2005 and lot 17054HW00 Exp November 17, 2005.
FEI Number 2018433
Recalling Firm/
Manufacturer		 Abbott Laboratories Diagnostic Div
820 Mission St
South Pasadena CA 91030-3142
For Additional Information ContactMark Littlefield
972-518-8218
Manufacturer Reason
for Recall		Precipitate formed in product.
FDA Determined
Cause 2		Other
ActionFirm sent recall letters requesting destruction of kits in the field on July 27, 2004.
Quantity in Commerce758
DistributionNationwide and to Mexico, Columbia, Ecuador, Brazil, Puerto Rico, Domincan Republic, Canada, Germany, Singapore, Hong Kong, India, Thailand, Australia, New Zealand, Bahamas.
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 = CGX
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