PLAC 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
FDA Recall Z-2400-2008 · Posted 2008-09-26
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Recalling FirmDiaDexus, Inc
Recall StatusTerminated
Product CodeNOE
Date Initiated2008-07-18
Date Terminated2009-12-22
Product Quantity65 (total)
Reason for Recall
Product may give Lp-PLA2 values at up to 22% lower than accurate values.
Firm 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.
Root Cause
Finished device change control
Distribution Pattern
US, OUS: UK and Germany.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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