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U.S. Department of Health and Human Services

Class 2 Device Recall AxSYM Homocysteine Reagent Pack

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  Class 2 Device Recall AxSYM Homocysteine Reagent Pack see related information
Date Initiated by Firm August 22, 2003
Date Posted September 11, 2003
Recall Status1 Terminated 3 on July 20, 2004
Recall Number Z-1218-03
Recall Event ID 27069
510(K)Number K992858  
Product Classification Urinary Homocystine (Nonquantitative) Test System - Product Code LPS
Product AxSYM Homocysteine Reagent Pack, list 5F51-20, Produced by Axis-Shield, Oslo, Norway, for Abbott Laboratories, Abbott Park, IL 60064 USA
Code Information list 5F51-20, lots 01724M300, 03314HN00, 03533HN00
Recalling Firm/
Manufacturer		 Abbott Laboratories HPD/ADD/GPRD
100/200 Abbott Park Road
Abbott Park IL 60064
For Additional Information Contact Customer Support Center
877-422-2688
Manufacturer Reason
for Recall		 There is a kit-to-kit difference within the lots, with the reagents generating different polarization values than those in others.
FDA Determined
Cause 2		 Other
Action Recall letters dated 8/22/03 informed users of the kit to kit difference within the lots, and outlined the actions needed to take for patient results obtained from the use of the affected kits. The customers were requested to destroy any remaining inventory of the affected reagents. Any questions were directed to Abbott's Customer Service at 1-877-422-2688.
Quantity in Commerce 3505 kits
Distribution Lot 01724M300 was distributed nationwide, as well as to Canada, Singapore, Tahiland, Korea, Hong Kong and China. Lots 03314HN00 and 03533HN00 were distributed by Abbott's Delkenheim, Germany subsidiary worldwide outside of the United States. These two lots were not distributed in the U.S.
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 = LPS and Original Applicant = ABBOTT LABORATORIES
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