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U.S. Department of Health and Human Services

Class 2 Device Recall PLAC Test ELISA Kit

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 Class 2 Device Recall PLAC Test ELISA Kitsee related information
Date Initiated by FirmJuly 18, 2008
Date PostedSeptember 26, 2008
Recall Status1 Terminated 3 on December 22, 2009
Recall NumberZ-2400-2008
Recall Event ID 49044
510(K)NumberK030477 
Product Classification Immunoassay test system - Product Code NOE
ProductPLAC Test ELISA kit, catalog number 90106, enzyme immunoassay for the quantitative determination of Lp-PLA2 in human plasma and serum, kit containing coated microwell stripplate and reagents (12 strips, 1 set calibrators 1 to 6, 0.25 ml each, 20x wash buffer, 50 mL, conjugate 23 mL, TMB, 11 mL, Stop solution, 11 mL
Code Information All lots
Recalling Firm/
Manufacturer		 DiaDexus, Inc
343 Oyster Point Blvd
South San Francisco CA 94080-1913
For Additional Information ContactRobert 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
ActionAll 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 Commerce65 (total)
DistributionUS, OUS: UK and Germany.
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 = NOE
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