BEUDAMED
    FDA Recall Terminated

    Dimension Total Prostate Specific Antigen (TPSA) Flex Reagent Cartridge (RF451). Siemens, Newark, DE 19714

    Recall: Z-1606-2008 · Initiated March 24, 2008

    Recall

    Recall Number
    Z-1606-2008
    Event Number
    47518
    Firm
    Siemens Healthcare Diagnostics Inc.
    Product Code
    MTF
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    March 24, 2008
    Posted
    June 28, 2008
    Terminated
    October 15, 2008
    Address
    500 GBC Drive P. O. Box 6101, Mailstop 514, Newark, DE, 19714-6101

    Description

    Dimension Total Prostate Specific Antigen (TPSA) Flex Reagent Cartridge (RF451). Siemens, Newark, DE 19714

    Reason

    False Results: The product may exhibit falsely elevated results. The affected lots demonstrate sporadic variability in recovery of calibrator and quality control; therefore this issue may not be readily detected upon calibration or during routine processing of Quality Control.

    Action

    The recalling firm issued a letter (Urgent Field Safety Notice) dated 3/25/08 to inform their customers to discontinue use of any remaining inventory, retest using an alternate lot for those samples from post-prostatectomy patients which recovered positive TPSA results less than 1.0 ng/nL. The firm has requested that you call the them for no-charge replacement product at 1-800-441-9250 and/or for technical assistance.

    Distribution

    The product was shipped to medical facilities nationwide. The product was also shipped to Germany, Singapore, Canada, Japan and AE

    Quantity

    1631 cartons