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U.S. Department of Health and Human Services

Class 2 Device Recall PLAC Test Reagent Kit

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  Class 2 Device Recall PLAC Test Reagent Kit see related information
Date Initiated by Firm July 18, 2008
Date Posted September 26, 2008
Recall Status1 Terminated 3 on December 22, 2009
Recall Number Z-2399-2008
Recall Event ID 49044
510(K)Number K030477  
Product Classification Immunoassay test system - Product Code NOE
Product PLAC Test Reagent Kit, Catalog numbers 90107 and 90110, Turbidimetric Immunoassay for the Quantitative Determination of Lp-PLA2 in human plasma or serum. Product consists of a liquid, ready to use, two reagent kit assembled in a kit box.
Code Information All lot codes under recall.
Recalling Firm/
Manufacturer		 DiaDexus, Inc
343 Oyster Point Blvd
South San Francisco CA 94080-1913
For Additional Information Contact Robert Wolfert
650-246-6400
Manufacturer Reason
for Recall		 Product may give Lp-PLA2 values at up to 22% lower than accurate values.
FDA Determined
Cause 2		 Finished device change control
Action All customers received communication of product correction dated July 18. 2008, via Federal Express, which included a cover letter, technical bulletin, specimen handling best practices cards, and revised package inserts. E-mail communication was also sent to all but seven customers. Contact diaDexus Technical Support at 1-877-752-2837 for assistance.
Quantity in Commerce 65 (total)
Distribution US, OUS: UK and Germany.
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 = NOE and Original Applicant = DIADEXUS, INC.
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