BEUDAMED
    FDA Recall Terminated

    diaDexus PLAC Test ELISA Kit; Manufactured and distributed by diaDexus , Inc., South San Francisco, CA; Model Part Number: 90123 The diaDexusPLAC Test ELISA Kit is an enzyme Immunoassay for the quantitative determination of Lp-PLA2 (lipoprotein-associated phospholipase A2) in human plasma and serum, to be used in conjunction with clinical evaluation and patient risk assessment as an aid in predicting risk for coronary hear disease, and ischemic stroke associated with atherosclerosis.

    Recall: Z-0429-2011 · Initiated March 15, 2010

    Recall

    Recall Number
    Z-0429-2011
    Event Number
    56017
    Firm
    DiaDexus, Inc
    FEI Number
    3003643666
    Product Code
    NOE
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 15, 2010
    Posted
    November 22, 2010
    Terminated
    January 11, 2011
    Address
    343 Oyster Point Blvd, South San Francisco, CA, 94080

    Description

    diaDexus PLAC Test ELISA Kit; Manufactured and distributed by diaDexus , Inc., South San Francisco, CA; Model Part Number: 90123 The diaDexusPLAC Test ELISA Kit is an enzyme Immunoassay for the quantitative determination of Lp-PLA2 (lipoprotein-associated phospholipase A2) in human plasma and serum, to be used in conjunction with clinical evaluation and patient risk assessment as an aid in predicting risk for coronary hear disease, and ischemic stroke associated with atherosclerosis.

    Reason

    The reason for the recall is that Real Time Stability Test program showed the kit lot failed stability prior to expiration, affecting samples with results> 500 ng/ml. Results up to 500 ng/ml exhibit passing stability results and are not impacted by this issue.

    Action

    DiaDexus notified all customers by phone, including distributor's customers, beginning on March 15, 2010. Customers were told to re-test samples that were tested from 2/1/2010 through 2/28/2010 which have values above 500 ng/ml with a new lot of product. For questions regarding this recall call (650) 246-6477.

    Distribution

    Nationwide Distribution - US including NJ, OH, KS, IN, FL, CA, UT, OK, PA, WA and MI.

    Quantity

    239 kits