BEUDAMED
    FDA Recall Terminated

    diaDexus PLAC Test ELISA Kit, Enzyme Immunoassay for Quantitative Determination of Lp-PLA2 in human plasma or serum, part number 90123, manufactured by diaDexus Inc, South San Francisco.

    Recall: Z-1737-2011 · Initiated August 20, 2010

    Recall

    Recall Number
    Z-1737-2011
    Event Number
    56639
    Firm
    DiaDexus, Inc
    FEI Number
    3003643666
    Product Code
    NOE
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    August 20, 2010
    Posted
    March 21, 2011
    Terminated
    March 21, 2011
    Address
    343 Oyster Point Blvd, South San Francisco, CA, 94080

    Description

    diaDexus PLAC Test ELISA Kit, Enzyme Immunoassay for Quantitative Determination of Lp-PLA2 in human plasma or serum, part number 90123, manufactured by diaDexus Inc, South San Francisco.

    Reason

    Product fails stability tests prior to expiration date.

    Action

    A phone script has been prepared to contact customers. Customers were informed of the affected product and its reason for the recall. If customers didn't use the product after May 11, 2010, the action is considered complete. If the product was used after May 11, 2010, a follow up letter will be sent to the customer and they will be asked to re-test any samples beyond May 11, 2010 with an alternate lot of reagent.

    Distribution

    Worldwide Distribution -- US, including states of UT, OH, CA, NJ, NC, FL, OK, MA, NY, TX, NJ, WA, and MI and countries of Germany and Israel.

    Quantity

    482 units