BEUDAMED
    FDA Recall Terminated

    PLAC Test Reagent Kit, immuno-turbidimetric method, Part Number 90107, 100 test kit, manufactured by DiaDexus, South San Francisco, CA.

    Recall: Z-1748-2010 · Initiated October 29, 2009

    Recall

    Recall Number
    Z-1748-2010
    Event Number
    53856
    Firm
    DiaDexus, Inc
    FEI Number
    3003643666
    Product Code
    NOE
    Status
    Terminated
    Root Cause
    Other
    Initiated
    October 29, 2009
    Posted
    June 3, 2010
    Terminated
    January 26, 2011
    Address
    343 Oyster Point Blvd, South San Francisco, CA, 94080

    Description

    PLAC Test Reagent Kit, immuno-turbidimetric method, Part Number 90107, 100 test kit, manufactured by DiaDexus, South San Francisco, CA.

    Reason

    Inaccurate results-- some samples may return with falsely elevated results potentially as a result of an interfering substance. Some patients may be subjected to additional lifestyle changes or intensified pharmaceutical therapy; such as statins, as a result of the falsely elevated result.

    Action

    Notification letter issued to consignees on 10/29/2009. Customers were instructed to not report PLAC test results for samples that are greater than 360 ng/mL, and pursue confirmatory testing by contacting DiaDexus. Customers with questions please call the company technical support line toll free at 1-877-752-2837 for assistance. UPDATE: On April 30, the firm suspended marketing of the PLAC TIA method, as the limited range no longer covered the clinical data/reference range data cited in the product insert. The firm sent out a letter notifying customers on May 10, 2010. The firm set up a sample send out program, so that customers can send samples to labs running the ELISA method PLAC test. Arrangements were made so that labs could be enabled to run a CLIA complex assay, for customer credit programs for un-used products, and a fax back response form for response tracking.

    Distribution

    Product was distributed to 123 consignees throughout the US.

    Quantity

    all lots