BEUDAMED
    FDA Recall Terminated

    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

    Recall: Z-2400-2008 · Initiated July 18, 2008

    Recall

    Recall Number
    Z-2400-2008
    Event Number
    49044
    Firm
    DiaDexus, Inc
    FEI Number
    3003643666
    Product Code
    NOE
    Status
    Terminated
    Root Cause
    Finished device change control
    Initiated
    July 18, 2008
    Posted
    September 26, 2008
    Terminated
    December 22, 2009
    Address
    343 Oyster Point Blvd, South San Francisco, CA, 94080-1913

    Description

    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

    Reason

    Product may give Lp-PLA2 values at up to 22% lower than accurate values.

    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.

    Distribution

    US, OUS: UK and Germany.

    Quantity

    65 (total)