Class 2 Device Recall PLAC Test Reagent Kit

• Date Initiated by Firm: July 18, 2008
• Date Posted: September 26, 2008
• Recall Status: Terminated 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: 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