BEUDAMED
    FDA Recall Terminated

    PLAC Test Calibrator Kit, Five-level liquid calibrator set for use with the diaDexus PLAC Test Reagent Kit, assembled in a kit box with an outer label, Catalog numbers 90108 and 10-0108, manufactured by diaDexus inc., South San Francisco, CA. Intended to establish points of reference that are used in the determination of values in the determination of Lp-PLA2 by the PLAC Test Reagent Kit.

    Recall: Z-1205-2009 · Initiated February 9, 2009

    Recall

    Recall Number
    Z-1205-2009
    Event Number
    51215
    Firm
    DiaDexus, Inc
    FEI Number
    3003643666
    Product Code
    NOE
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    February 9, 2009
    Posted
    April 23, 2009
    Terminated
    January 5, 2010
    Address
    343 Oyster Point Blvd, South San Francisco, CA, 94080

    Description

    PLAC Test Calibrator Kit, Five-level liquid calibrator set for use with the diaDexus PLAC Test Reagent Kit, assembled in a kit box with an outer label, Catalog numbers 90108 and 10-0108, manufactured by diaDexus inc., South San Francisco, CA. Intended to establish points of reference that are used in the determination of values in the determination of Lp-PLA2 by the PLAC Test Reagent Kit.

    Reason

    Premature Expiration-- the product is projected to fall short of expected shelf life, and may result in inaccurate results.

    Action

    Distributors and Direct accounts were notified by phone followed by Notification letter and certificate of destruction via FedEx. International customers were notified via e-mail with PDF copies of notices, to be followed by hard copies via FedEx. Customers are requested to record the number of kits (full and partial ) they had on the Certificate of Destruction and to dispose of that number of kits with two people signing the form, and then to fax that form to diaDexus.

    Distribution

    Worldwide Distribution

    Quantity

    105 kits